Regulatory Updates 2025
Regulatory Update - 401
We added new standards to the Monitored Requirements and added the Description (Definition and Regulatory Source) of Unit of Use DI in the UDI-DI Collection.
New standards now part of our monitoring are:
No | Reference of the standard |
| ANSI/AAMI ST98:2022 | Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices |
| EN 60601-2-18:2015 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| EN IEC 60601-2-2:2018/A1:2024 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| EN ISO 11139:2018/A1:2024 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards Amendment 1: Amended and additional terms and definitions |
| EN ISO 15883-5:2021 | Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy |
| EN ISO 16061:2021 | Instruments for use in association with non-active surgical implants — General requirements |
| EN ISO 7153-1:2016 | Surgical instruments — Materials Part 1: Metals |
| ISO 8600-1:2025 | Endoscopes — Medical endoscopes and endotherapy devices Part 1: General requirements |
| ISO 8600-4 | Endoscopes — Medical endoscopes and endotherapy devices Part 4: Determination of maximum width of insertion portion |
| ISO 8600-6:2020 | Endoscopes — Medical endoscopes and endotherapy devices Part 6: Vocabulary |
The duplicate entry of the EN ISO 10993-9:2021 in our monitoring has now been deleted.
Regulatory Update - 400
We made some minor changes to the meddevo Document Templates List of Applied Standards DE/EN, eTD EU-MDR Summary, Product Groups EU-MDR Summary & Products EU-MDR Summary EN. These templates used a sorting that was no longer functional.
Regulatory Update - 399
New revision: MDCG 2024-14 rev. 1 is updated in the system. Find the updated position paper here.
Regulatory Update - 394
In the Collection "Countries & Regions" we added a reference to "Languages" that can contains all official languages of the specific country or region
Regulatory Update - 393
In the Collections "eTD", "Product Group" and "Product" you can find the Formfield "Market Status". We have added the new values:
- "Out of Production"
- "Out of Market"
In the Collection "Applicable Requirements" you can now display the Information about harmonization (yes/no) if your requirements are connected to a Monitored Requirement
Regulatory Update - 392
Small tweaks concerning the Inspector for IVDR products. We changed the Inspector level to WARNING instead of ERROR for:
- "For Instruments of Automated Assays: Description of the Appropriate Assay Characteristics or Dedicated Assays"
- "For Automated assays: A Description of the Appropriate Instrumentation Characteristics or Dedicated Instrumentation"
Regulatory Update - 391
In the Collection "Components" we added a few background tweaks to ensure that all relevant supplier documents related to this component are correctly displayed.
Regulatory Update - 390
In the Collection "Document Templates" meddevo now offers a new view that displays no withdrawn templates.
Regulatory Update - 389
New Position Paper - MDCG 2025-7: Timelines of implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
Find the position paper here.
Regulatory Update - 388
We added the MDCG 2019-13 rev.1: Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (June 2025) to our monitoring. Previously, we still had the MDCG 2019-13 (without revision) in the system.
Find the updated position paper here.
We continue to mark legacy document templates as (Archived).
Regulatory Update - 387
New Position Paper - MDCG 2025-5: Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746. Find the position paper here.
New Position Paper - MDCG 2025-6: FAQ on Interplay between the Medical Devices Regulation & In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act (June 2025). Find the position paper here.
Several more legacy document templates are not marked as (Archived). These templates should not be used, they do not reflect the current state of regulatory configuration in meddevo. The renaming should make it more easy to recognize and avoid them.
Regulatory Update - 386
New MDCG Revision – MDCG 2019-11 rev.1: Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (June 2025) Find the updated position paper here.
Regulatory Update - 385
New Position Paper - MDCG 2025-4: Guidance on the safe making available of medical device software (MDSW) apps on online platforms. Find the position paper here.
Several legacy document templates are not marked as (Archived). These templates should not be used, they do not reflect the current state of regulatory configuration in meddevo. The renaming should make it more easy to recognize and avoid them.
Regulatory Update - 384
We created "DMS & Approval" and "QM" roles in the access control management to further improve alignment between our user roles and future licensing models.
Regulatory Update - 383
Update of Complaint Handling, Change Control and CAPA Management (setup of references to link those processes to each other).
We created new Roles (eTD Full User, Clinical Affairs, Post-Market Surveillance, Research & Development, Submissions/Registrations) to improve alignment between our user roles and future licensing models.
We renamed the old Document Templates for List of Applied Standards to (Archive).
We have new Connections available to show all supplier relevant documents in each level of folder previews.
Regulatory Update - 382
We had some unnecessary filters applied in the "Applied Regulatory Requirements" Formfield on eTD, PG and P. These filters have now been removed.
Regulatory Update - 381
We have corrected the Workflow User - Document Preview is now available within the Workflow Process
Regulatory Update - 380
We have archived the "Applied Standard" Formfield on eTD, PG and P. It will in the future be replaced by the new"Applied Regulatory Requirements".
The User Role "Read only" was updated and is allowed to comment now.
"Workflow User" role was updated to see document preview within the workflow process.
The following standards from our monitoring have been updated with a new version:
No | Reference of the standard |
| DIN EN ISO 14630:2025-03 | Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2024); Deutsche Fassung EN ISO 14630:2024 |
| DIN EN ISO 80369-20:2025-03 | Verbindungsstücke mit kleinem Durchmesser für Flüssigkeiten und Gase in medizinischen Anwendungen - Teil 20: Allgemeine Prüfverfahren (ISO 80369-20:2024); Deutsche Fassung EN ISO 80369-20:2024 |
Regulatory Update - 379
We added the formfield "Conditions of Use/Use Environment" into the Portfolio Collections eTD, ProductGroups and Products. They are now displayed in our standard view but not used in any templates.
If you use your own custom view, please review if you want to use this formfield. Sames goes for your templates.
New Standards that we added to our Monitoring:
No | Reference of the standard |
| ISO 1135-4:2025 | Transfusion equipment for medical use Part 4: Transfusion sets for single use, gravity feed |
| ISO 1135-5:2025 | Transfusion equipment for medical use Part 5: Transfusion sets for single use with pressure infusion apparatus |
Regulatory Update - 378
Implementing Decisions 2025/679 (MDR) and 2025/681 (IVDR) harmonized standards covering sterilization, medical gloves and patient handling equipment.
For the IVDR, the following standards have been harmonized:
No | Reference of the standard |
| ‘16. | EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices |
| 17. | EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 2: Requirements for aseptically processed medical devices’ |
For the MDR, the following standards have been harmonized:
No | Reference of the standard |
| ‘27. | EN 455-1:2020+A2:2024 Medical gloves for single use – Part 1: Requirements and testing for freedom of holes |
| 28. | EN 455-2:2024 Medical gloves for single use – Part 2: Requirements and testing for physical properties |
| 29. | EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" – Part 1: Requirements for terminally sterilized medical devices |
| 30. | EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" – Part 2: Requirements for aseptically processed medical devices |
| 31. | EN 1865-2:2024 Patient handling equipment used in ambulances – Part 2: Power assisted stretcher |
| 32. | EN 1865-6:2024 Patient handling equipment used in ambulances – Part 6: Powered chairs’. |
The following norms have been added to the meddevo monitoring:
| EN 10060:2003 | Hot rolled round steel bars for general purposes - Dimensions and tolerances on shape and dimensions |
| EN 10088-3:2023 | Stainless steels - Part 3: Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resistant steels for general purposes |
| EN 10204:2004 | Metallic products - Types of inspection documents |
| EN 13060:2014+A1:2018 | Small steam sterilizers |
| EN 1639:2009 | Dentistry - Medical devices for dentistry - Instruments |
| EN 1865-2:2024 | Patient handling equipment used in ambulances - Part 2: Power assisted stretcher |
| EN 1865-6:2024 | Patient handling equipment used in ambulances - Part 6: Powered chairs |
| EN 22248:1992 | Packaging - Complete, filled transport packages - Vertical impact test by dropping (ISO 2248:1985) |
| EN 455-1:2020+A2:2024 | Medical gloves for single use – Part 1: Requirements and testing for freedom of holes |
| EN 455-2:2024 | Medical gloves for single use - Part 2: Requirements and testing for physical properties |
| EN 556-1:2024 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| EN 556-2:2024 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
| EN ISO 10323:2013 | Dentistry - Bore diameters for rotary instruments such as discs and wheels (ISO 10323:2013) |
| EN ISO 13295:2007 | Dentistry - Mandrels for rotary instruments (ISO 13295:2007) |
| EN ISO 13485:2016, EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
| EN ISO 14155:2020/A11:2024 | Clinical investigation of medical devices for human subjects - Good clinical practice |
| EN ISO 14971:2019, EN ISO 14971:2019/A11:2021 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
| EN ISO 1797:2017 | Dentistry - Shanks for rotary and oscillating instruments (ISO 1797:2017) |
| EN ISO 21531:2009 | Dentistry - Graphical symbols for dental instruments (ISO 21531:2009) |
| EN ISO 2157:2016 | Dentistry - Nominal diameters and designation code numbers for rotary instruments (ISO 2157:2016) |
| EN ISO 21671:2006/A1:2011 | Dentistry - Rotary polishers - Amendment 1 (ISO 21671:2006/Amd 1:2011) |
| EN ISO 21850-1:2020 | Dentistry - Materials for dental instruments - Part 1: Stainless steel (ISO 21850-1:2020) |
| EN ISO 25424:2019 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |
| EN ISO 3630-2:2023 | Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2023) |
| EN ISO 3823-1:1998 | Dental rotary instruments - Burs - Part 1: Steel and carbide burs (ISO 3823-1:1997) |
| EN ISO 3823-2:2003/A1:2008 | Dentistry - Rotary bur instruments - Part 2: Finishing burs - Amendment 1 (ISO 3823-2:2003/Amd 1:2008) |
| EN ISO 5840-1:2021/A1:2025 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/Amd 1:2025) |
| EN ISO 5840-2:2021/A1:2025 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025) |
| EN ISO 5840-3:2021/A1:2025 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025) |
| EN ISO 6360-1:2004/AC:2007 | Dentistry - Number coding system for rotary instruments - Part 1: General characteristics (ISO 6360-1:2004/Cor 1:2007) |
| EN ISO 6360-1:2004/AC:2007 | Dentistry - Number coding system for rotary instruments - Part 1: General characteristics (ISO 6360-1:2004/Cor 1:2007) |
| EN ISO 6360-2:2004/A1:2011 | Dentistry - Number coding system for rotary instruments - Part 2: Shapes - Amendment 1 (ISO 6360-2:2004/Amd 1:2011) |
| EN ISO 6360-3:2005 | Dentistry - Number coding system for rotary instruments - Part 3: Specific characteristics of burs and cutters (ISO 6360-3:2005) |
| EN ISO 6360-4:2004 | Dentistry - Number coding system for rotary instruments - Part 4: Specific characteristics of diamond instruments (ISO 6360-4:2004) |
| EN ISO 6360-6:2004 | Dentistry - Number coding system for rotary instruments - Part 6: Specific characteristics of abrasive instruments (ISO 6360-6:2004) |
| EN ISO 6360-7:2006 | Dentistry - Number coding system for rotary instruments - Part 7: Specific characteristics of mandrels and special instruments (ISO 6360-7:2006) |
| EN ISO 6507-1:2023 | Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2023) |
| EN ISO 6507-2:2018 | Metallic materials - Vickers hardness test - Part 2: Verification and calibration of testing machines (ISO 6507-2:2018) |
| EN ISO 7711-1:2021/A1:2025 | Dentistry - Diamond rotary instruments - Part 1: General requirements - Amendment 1 (ISO 7711-1:2021/Amd 1:2025) |
| EN ISO 7711-2:2011 | Dentistry - Rotary diamond instruments - Part 2: Discs (ISO 7711-2:2011) |
| EN ISO 7786:2001 | Dental rotary instruments - Laboratory abrasive instruments (ISO 7786:2001) |
| EN ISO 7787-1:2016 | Dentistry - Laboratory cutters - Part 1: Steel laboratory cutters (ISO 7787-1:2016) |
| EN ISO 7787-2:2020 | Dentistry - Laboratory cutters - Part 2: Carbide laboratory cutters (ISO 7787-2:2020) |
| EN ISO 7787-3:2017 | Dentistry - Laboratory cutters - Part 3: Carbide cutters for milling machines (ISO 7787-3:2017) |
| EN ISO 7787-4:2002 | Dental rotary instruments - Cutters - Part 4: Miniature carbide laboratory cutters (ISO 7787-4:2002) |
| EN ISO 8325:2023 | Dentistry - Test methods for rotary instruments (ISO 8325:2023) |
| EN ISO 9687:2015/A1:2018 | Dentistry - Graphical symbols for dental equipment (ISO 9687:2015/Amd 1:2018) |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 15883-1:2024-10 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| ISO 3951-1:2022 | Sampling procedures for inspection by variables — Part 1: Specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality characteristic and a single AQL |
| ISO 7405:2018 | Dentistry — Evaluation of biocompatibility of medical devices used in dentistry |
| ISO/TR 10993-22:2017 | Biological evaluation of medical devices Part 22: Guidance on nanomaterials |
| VDI/ VDE 2602 Part 2: 2018-04 | Roughness measurement - Roughness measurement using contact (stylus) instruments (profile method) - Set-up, measurement conditions, procedure |
| VDI/ VDE 2602 Part 4: 2014-09 | Surface measurement - Roughness measurement using contact (stylus) instruments - Calibration, uncertainty of measurement |
| VDI/VDE/DGQ 2618 Part 1.1:2021-07 | Inspection of measuring and test equipment - Instructions to inspect measuring and test equipment for geometrical quantities - Basic principles |
| VDI/VDE/DGQ 2618 Part 1.2:2003-12 | Inspection of measuring and test equipment - Instructions for the inspection of measuring and test equipment for geometrical quantities - Uncertainty of measurement |
| VDI/VDE/DGQ 2618 Part 10.1:2001-11 | Inspection of measuring and test equipments - Test instructions for micrometers |
| VDI/VDE/DGQ 2618 Part 11.1:2021-08 | Inspection of measuring and test equipment - Test instruction for mechanical dial gauges |
| VDI/VDE/DGQ 2618 Part 11.2:2002-08 | Inspection of measuring and test equipment - Test instructions for dial indicators for linear measurement with mechanical indication |
| VDI/VDE/DGQ 2618 Part 11.3:2002-09 | Inspection of measuring and test equipment - Test instructions for lever gauges |
| VDI/VDE/DGQ 2618 Part 14.1:2010-08 | Inspection of measuring and test equipment - Test instruction for electrical linear measuring devices consisting of inductive probe and measuring device |
| VDI/VDE/DGQ 2618 Part 19.1:2014-11 | Inspection of measuring and test equipment - Test instruction for special gauges and test equipment |
| VDI/VDE/DGQ 2618 Part 3.1:2004-01 | Inspection of measuring and test equipment - Test instruction for gauge blocks |
| VDI/VDE/DGQ 2618 Part 4.2:2007-07 | Inspection of measuring and test equipment - Test instruction for cylindrical measuring pins/pins for screw threads |
| VDI/VDE/DGQ 2618 Part 9.1:2006-03 | Inspection of measuring and test equipment - Test instruction for callipers for external, internal and depth dimensions |
Regulatory Update - 377
Again a minor update that brought some cosmetic changed to the collection "Basic UDI-DI" and some improved german translations.
Regulatory Update - 376
With this minor update we have corrected some german translations in meddevo.
Regulatory Update - 375
As previously announced, the EMDN codes that have been officially deleted have now been deleted in meddevo - for more details, see Regulatory Update 363 below.
Regulatory Update - 374
Today we have no news ;) A small test was performed that required use of our update function - but all meddevo functionality stay untouched.
Regulatory Update - 373
Some legacy word templates in meddevo have been removed.
Regulatory Update - 372
Due to some changes in the background the Collection " Residual Risk" was temporarily not available. It is now up and of course all data in it stays untouched.
Regulatory Update - 371
As meddevo now offers a full GSPR module (for MDR), the old GSPR Template has been removed.
Regulatory Update - 370
Our standard monitoring did previously contain a collection called "Regulatory Requirements" that will from now on be named "Monitored Requirements". It has been renamed accordingly.
meddevo now provides a new template: "List of Similar Devices (EN)"
Regulatory Update - 369
meddevo now provides a new template: "Risk Management Summary"
Regulatory Update - 368
In the Document Collection, you can now mark Documents as "Document Evaluation required". Checking this box will open a new editor field in which the result of the evaluation can be documented.
The MDCG 2020-16 rev.3 has been updated to MDCG 2020-16 rev.4.
Find the new version here.
Regulatory Update - 367
meddevo has taken several new norms into monitoring, most of which are part of the 10993-series:
| DIN EN ISO 10993-2:2023-02 | Biologische Beurteilung von Medizinprodukten - Teil 2: Tierschutzbestimmungen (ISO 10993-2:2022); Deutsche Fassung EN ISO 10993-2:2022 |
| DIN EN ISO 10993-3:2015-02 | Biologische Beurteilung von Medizinprodukten - Teil 3: Prüfungen auf Gentoxizität, Karzinogenität und Reproduktionstoxizität (ISO 10993-3:2014); Deutsche Fassung EN ISO 10993-3:2014 |
| DIN EN ISO 10993-4:2017-12 | Biologische Beurteilung von Medizinprodukten - Teil 4: Auswahl von Prüfungen zur Wechselwirkung mit Blut (ISO 10993-4:2017); Deutsche Fassung EN ISO 10993-4:2017 |
| DIN EN ISO 10993-7:2022-09 | Biologische Beurteilung von Medizinprodukten - Teil 7: Ethylenoxid-Sterilisationsrückstände (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); Deutsche Fassung EN ISO 10993-7:2008 + AC:2009 + A1:2022 |
| EN ISO 10993-2:2022 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022 |
| EN ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014 |
| EN ISO 10993-4:2017/A1:2025 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood Amendment 1 |
| EN ISO 10993-5:2009/A11:2025 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009); German version EN ISO 10993-5:2009/A11:2025 |
| EN ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
| EN ISO 10993-7:2008/A1:2022 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009 + Amd 1:2019); German version EN ISO 10993-7:2008 + AC:2009 + A1:2022 |
| EN ISO 10993-9:2021 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019); German version EN ISO 10993-9:20 |
| EN ISO 10993-10:2023 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021); German version EN ISO 10993-10:2023 |
| ISO 10993-1:2018 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-2:2022 | Biological evaluation of medical devices Part 2: Animal welfare requirements |
| ISO 10993-3:2014 | Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
| ISO 10993-7:2008/Amd 1:2019 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals Amendment 1: Applicability of allowable limits for neonates and infants |
| ISO 10993-9:2019 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 10993-10:2021 | Biological evaluation of medical devices Part 10: Tests for skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices Part 11: Tests for systemic toxicity |
| ISO 10993-12:2021 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-13:2010 | Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices |
Regulatory Update - 366
There is a new amendment to the ISO 15223-1:2021: Amd 1:2025. The Amendment comes with an addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific
In the collection Storage and Transportation Condition we now made the "Storage and Transportation Condition" field is required - in the past it was able to create completely empty entries.
Regulatory Update - 365
In the collection Contact Lists, you can now use two new Positions: PRRC and Business Development Manager.
In the collection Countries & Regions we added the information "Countries related to this Region". So when you now select "European Union" you can display all corresponding countries with it too.
Regulatory Update - 364
The MDCG 2019-6 rev.4 has been updated to MDCG 2019-6 rev.5.
Find the new version here.
Regulatory Update - 363
With this again rather big update we added and changed EMDN Codes according to the changes published in MDCG 2025-2 and MDCG 2025-3.
Please take into consideration, that we did not yet take out the codes that have been deleted!
We want to give all users adequate time to acknowledge the changes to these codes and take appropriate action, if necessary.
The following set of codes WILL BE CHANGED in a future update:
| Code | Term | Type of Change | Change Term (in case of modification) |
| C020303 | ARRHYTHMOGENIC FOCI ABLATION LEADS VIA OTHER ENERGY SOURCES | DELETION | The code is no longer present in the EMDN V2. Refer to type C0203 |
| R900601 | PHONATION VALVES FOR TRACHEOSTOMIC CANNULA | DELETION | The code is no longer present in the EMDN V2. Refer to type R9006 |
| W0102039012 | PROTEIN S-100 B | DELETION | The code is no longer present in the EMDN V2. Replaced by W01021702 |
| W0102109018 | SACCHAROMYCES CEREVISIAE ANTIBODIES | DELETION | The code is no longer present in the EMDN V2. Replaced by W0102100801 |
| W0105040519 | CORONAVIRUS - NA REAGENTS | DELETION | The code is no longer present in the EMDN V2. Replaced by W0105041106 |
| W0105040619 | CORONAVIRUS | DELETION | The code is no longer present in the EMDN V2. Replaced by more granular terminal levels under W01050411 |
| W0105050211 | TRICHOMONAS - NA REAGENTS | DELETION | The code is no longer present in the EMDN V2. Replaced by W0105050310 |
The following codes have been changed with this regulatory update and are available now:
| Code | Term | Type of Change | Change Term (in case of modification) |
| A108009 | ABDOMINAL OSTOMY DILATORS | INSERTION OF A NEW CODE | |
| A13 | APPLICATORS FOR DRUGS AND MEDICAL DEVICES NOT PRESENT IN OTHER CLASSES | INSERTION OF A NEW CODE | |
| C020101 | ARRHYTHMOLOGY BIPOLAR LEADS | MODIFIED TERM | New term: ARRHYTHMOLOGY BIPOLAR DIAGNOSTIC CATHETERS |
| C020102 | ARRHYTHMOLOGY TRIPOLAR LEADS | MODIFIED TERM | New term: ARRHYTHMOLOGY TRIPOLAR DIAGNOSTIC CATHETERS |
| C020103 | ARRHYTHMOLOGY TETRAPOLAR LEADS | MODIFIED TERM | New term: ARRHYTHMOLOGY TETRAPOLAR DIAGNOSTIC CATHETERS |
| C02010401 | ARRHYTHMOLOGY MULTIPOLAR LEADS, CONVENTIONAL | MODIFIED TERM | New term: ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL |
| C02010402 | ARRHYTHMOLOGY MULTIPOLAR LEADS, BASKET TYPE | MODIFIED TERM | New term: ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, BASKET TYPE |
| C02010403 | ARRHYTHMOLOGY MULTIPOLAR LEADS, ADJUSTABLE | MODIFIED TERM | New term: ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE |
| C02010499 | ARRHYTHMOLOGY MULTIPOLAR LEADS - OTHER | MODIFIED TERM | New term: ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS – OTHER |
| C020105 | NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL LEADS | MODIFIED TERM | New term: NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS |
| C020301 | ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION LEADS | MODIFIED TERM | New term: ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS |
| C020302 | ARRHYTHMOGENIC FOCI CRYOENERGY ABLATION LEADS | MODIFIED TERM | New term: ARRHYTHMOGENIC FOCI CRYOENERGY ABLATION CATHETERS |
| C020304 | ARRHYTHMOGENIC FOCI PULSED FIELD ABLATION CATHETERS | INSERTION OF A NEW CODE | |
| C020305 | ARRHYTHMOGENIC FOCI LASER ABLATION CATHETERS | INSERTION OF A NEW CODE | |
| G06 | ANAL DILATORS | INSERTION OF A NEW CODE | |
| L050906 | GYNECOLOGICAL PROSTHETIC INSTRUMENTS AND KIT, REUSABLE | INSERTION OF A NEW CODE | |
| L0612 | UROLOGY PROSTHETIC INSTRUMENTS AND KIT, REUSABLE | INSERTION OF A NEW CODE | |
| L181001 | ELECTROSURGERY SINGLE PATIENT PADS (NEUTRAL ELECTRODES), REUSABLE | INSERTION OF A NEW CODE | |
| L181002 | ELECTROSURGERY DUAL PATIENT PADS (NEUTRAL ELECTRODES), REUSABLE | INSERTION OF A NEW CODE | |
| L181003 | ELECTROSURGERY CONNECTION CABLES, REUSABLE | INSERTION OF A NEW CODE | |
| L1904 | ARTHROSCOPIC SURGERY FORCEPS, REUSABLE | MODIFIED TERM | New term: ARTHROSCOPIC SURGERY FORCEPS AND PUNCHES, REUSABLE |
| L1909 | ARTHROSCOPIC SURGERY SCALPELS, REUSABLE | MODIFIED TERM | New term: ARTHROSCOPIC SURGERY SCALPELS, MENISCOTOMES AND KNIVES REUSABLE |
| L1918 | MICROFRACTORS FOR BONE STIMULATION, REUSABLE | INSERTION OF A NEW CODE | |
| L1919 | ARTHROSCOPIC SURGERY SPOONS AND CURETTES, REUSABLE | INSERTION OF A NEW CODE | |
| L1920 | ARTHROSCOPIC SURGERY FILES AND RASPS, REUSABLE | INSERTION OF A NEW CODE | |
| L1921 | ARTHROSCOPIC SURGERY PROBES, REUSABLE | INSERTION OF A NEW CODE | |
| P01010401 | PROSTHESES, ORBITAL CAVITY - PARTIAL | INSERTION OF A NEW CODE | |
| P01010402 | PROSTHESES, ORBITAL CAVITY - TOTAL | INSERTION OF A NEW CODE | |
| P0103 | PROSTHESES, CRANIAL | INSERTION OF A NEW CODE | |
| P0199 | FACIAL AND ODONTOLOGICAL PROSTHESES - OTHER | MODIFIED TERM | New term: PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL - OTHERS |
| P09010301 | SHOULDER PROSTHESIS AND METAGLENE METAL BACK | MODIFIED TERM | New term: METAL BACK AND METAGLENE GLENOID BASEPLATES |
| P9005 | IMPLANTABLE SPACERS FOR PROTECTION DURING RADIATION THERAPY | INSERTION OF A NEW CODE | |
| R90060201 | PHONATION VALVES FOR TRACHEOSTOMY FOR VENTILATOR USE | INSERTION OF A NEW CODE | The insertion of the code is based on the split of R900602 |
| R90060202 | PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE | INSERTION OF A NEW CODE | The insertion of the code is based on the split of R900602 |
| W0102069017 | MID-REGIONAL PROADRENOMEDULLIN (MR-PROADM) | INSERTION OF A NEW CODE | |
| W0102090102 | AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) | MODIFIED TERM | New term: AMPHETAMINE/METHAMPHETAMINE SPECIFIC. |
| W0102090118 | DEXTROMETHORPHAN | INSERTION OF A NEW CODE | |
| W0102090119 | MDMA (ECSTASY) | INSERTION OF A NEW CODE | |
| W0102090120 | EDDP SPECIFIC (METHADONE METABOLITES) | INSERTION OF A NEW CODE | |
| W0102090121 | TRAMADOL | INSERTION OF A NEW CODE | |
| W0102090122 | FENTANYL | INSERTION OF A NEW CODE | |
| W0102090123 | OXYCODINE | INSERTION OF A NEW CODE | |
| W0102100504 | APLS SCREENING (OR ANTI-CARDIOLIPIN / ANTI-B2-GLYCOPROTEIN COMBITEST) | INSERTION OF A NEW CODE | |
| W0102100801 | SACCHAROMYCES CEREVISIAE ANTIBODIES | INSERTION OF A NEW CODE | |
| W0102100802 | PERINUCLEAR ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODIES | INSERTION OF A NEW CODE | |
| W0102100899 | OTHERS INFLAMATORY BOWEL DISEASE | INSERTION OF A NEW CODE | |
| W01021315 | COPEPTIN | INSERTION OF A NEW CODE | |
| W01021316 | MID-REGIONAL PRO ATRIAL NATRIURETIC PEPTIDE (MR-PROANP) | INSERTION OF A NEW CODE | |
| W01021701 | GLIAL FIBRILLARY ACIDIC PROTEIN / UBIQUITIN C-TERMINAL HYDROLASE-L1 | INSERTION OF A NEW CODE | |
| W01021702 | PROTEIN S-100 B | INSERTION OF A NEW CODE | |
| W01021799 | OTHER TRAUMATIC BRAIN INJURY MARKERS | INSERTION OF A NEW CODE | |
| W0103020215 | COAGULATION FACTOR VON WILLEBRAND | MODIFIED TERM | New term: COAGULATION FACTOR VON WILLEBRAND (AG) |
| W0103020309 | ANTI XA ACTIVITY FOR DOAC | MODIFIED TERM | New term: ANTI XA ACTIVITY FOR HEPARIN AND DOAC |
| W0103020311 | ADAMTS13 (ACTIVITY, AG, AB, INHIBITOR) SPECIFIC VON WILLEBRAND FACTOR (VWF) - CLEAVING PROTEASE | INSERTION OF A NEW CODE | |
| W0103020615 | COAGULATION INHIBITORS/THROMBOPHILIA MARKERS FOR HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT) | INSERTION OF A NEW CODE | |
| W0103020806 | HEPARIN INDUCED THROMBOCYTOPENIA TEST (HIT) RT & POC | INSERTION OF A NEW CODE | |
| W0104010306 | ALL DEHYDRATED CULTURE MEDIA IN BOTTLES | MODIFIED TERM | New term: CULTURE MEDIA IN BOTTLES |
| W0104080602 | NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA | MODIFIED TERM | New term: NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED MRSA AND/OR MSSA |
| W0104080608 | NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED ESBL / CARBAPENEMASE COMBINED | INSERTION OF A NEW CODE | |
| W0105010704 | TB-IGRA (INTERFERON-‐GAMMA-‐RELEASE ASSAY) | INSERTION OF A NEW CODE | |
| W0105040532 | MONKEYPOX VIRUS / MPOX - NA REAGENT | INSERTION OF A NEW CODE | |
| W0105041101 | CORONAVIRUS AG | INSERTION OF A NEW CODE | |
| W0105041102 | CORONAVIRUS ANTIBODIES - TOTAL | INSERTION OF A NEW CODE | |
| W0105041103 | CORONAVIRUS IGG | INSERTION OF A NEW CODE | |
| W0105041104 | CORONAVIRUS IGM | INSERTION OF A NEW CODE | |
| W0105041105 | CORONAVIRUS IGA | INSERTION OF A NEW CODE | |
| W0105041106 | CORONAVIRUS - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105041199 | OTHER CORONAVIRUS REAGENTS | INSERTION OF A NEW CODE | |
| W0105050301 | ENTAMOEBA HISTOLYTICA - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050302 | CHAGAS - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050303 | DISTOMATOSIS - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050304 | ECHINOCOCCUS - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050305 | LEISHMANIA - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050306 | SCHISTOSOMA - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050307 | CRYPTOSPORIDIUM - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050308 | GIARDIA LAMBLIA - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050309 | PLASMODIUM (MALARIA) - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050310 | TRICHOMONAS - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105050399 | OTHER PARASITOLOGY - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105060404 | CANDIDA AURIS - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105060405 | PNEUMOCYSTIS - NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105070304 | INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) - MULTIPLEX NA REAGENTS | MODIFIED TERM | New term: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS |
| W0105070501 | STDS (C.TRACHOMATIS, N.GONORRHOEAE, M.GENITALIUM, T.VAGINALIS….) COMBINATION - MULTIPLEX NA REAGENTS | MODIFIED TERM | New term: STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS |
| W0105070507 | TICK BORNE DISEASES - MULTIPLEX NA REAGENTS | INSERTION OF A NEW CODE | |
| W0105090501 | CORONAVIRUS ANTIGEN (AG) - RT & POC | INSERTION OF A NEW CODE | |
| W0105090502 | CORONAVIRUS ANTIBODY (AB) - RT & POC | INSERTION OF A NEW CODE | |
| W0105090599 | OTHER CORONAVIRUS - RT & POC | INSERTION OF A NEW CODE | |
| W0105090601 | CORONAVIRUS / INFLUENZA - RT & POC | INSERTION OF A NEW CODE | |
| W0105090699 | OTHER MULTIPLE PATHOGENS - RT & POC | INSERTION OF A NEW CODE | |
| W0105099008 | MONKEYPOX VIRUS / MPOX RT & POC | INSERTION OF A NEW CODE | |
| W0106010116 | OTHER THROMBOPHILIA MUTATIONS (PROC, PROS1, MTHFR, SERPINC1, SEPINE1, F11, F12, F13, OTHER F2/F5) | INSERTION OF A NEW CODE | |
| W0106010117 | OTHER HEMOPHILIA MUTATIONS (VWF, F8, F9) | INSERTION OF A NEW CODE | |
| W0106030103 | CYP2C9 | INSERTION OF A NEW CODE | |
| W0106030104 | CYP2C19 | INSERTION OF A NEW CODE | |
| W0106030105 | VKORC1 | INSERTION OF A NEW CODE | |
| X01010101 | CONTACT LENSES WITHOUT AN INTENDED MEDICAL PURPOSE – HYDROGEL, DAILY SINGLE-USE | INSERTION OF A NEW CODE | |
| X01010102 | CONTACT LENSES WITHOUT AN INTENDED MEDICAL PURPOSE – HYDROGEL, EXTENDED WEAR SINGLE-USE | INSERTION OF A NEW CODE | |
| X010102 | CONTACT LENSES WITHOUT AN INTENDED MEDICAL PURPOSE – HYDROGEL, REUSABLE | INSERTION OF A NEW CODE | |
| X0102 | CONTACT LENSES WITHOUT AN INTENDED MEDICAL PURPOSE – NON HYDROGEL | INSERTION OF A NEW CODE | |
| X020101 | PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE TOTALLY INTRODUCED INTO THE HUMAN BODY THROUGH SURGICALLY INVASIVE MEANS FOR THE PURPOSE OF MODIFYING THE ANATOMY OF BODY PARTS WITH THE EXCEPTION OF TATTOOING PRODUCTS AND PIERCINGS – RESORBABLE | INSERTION OF A NEW CODE | |
| X020102 | PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE TOTALLY INTRODUCED INTO THE HUMAN BODY THROUGH SURGICALLY INVASIVE MEANS FOR THE PURPOSE OF MODIFYING THE ANATOMY OF BODY PARTS WITH THE EXCEPTION OF TATTOOING PRODUCTS AND PIERCINGS – NON RESORBABLE | INSERTION OF A NEW CODE | |
| X020201 | PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE PARTIALLY INTRODUCED INTO THE HUMAN BODY THROUGH SURGICALLY INVASIVE MEANS FOR THE PURPOSE OF MODIFYING THE ANATOMY OF BODY PARTS WITH THE EXCEPTION OF TATTOOING PRODUCTS AND PIERCINGS – RESORBABLE | INSERTION OF A NEW CODE | |
| X020202 | PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE PARTIALLY INTRODUCED INTO THE HUMAN BODY THROUGH SURGICALLY INVASIVE MEANS FOR THE PURPOSE OF MODIFYING THE ANATOMY OF BODY PARTS WITH THE EXCEPTION OF TATTOOING PRODUCTS AND PIERCINGS – NON RESORBABLE | INSERTION OF A NEW CODE | |
| X0301 | SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE | INSERTION OF A NEW CODE | |
| X0302 | SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – NON RESORBABLE | INSERTION OF A NEW CODE | |
| X0303 | SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – RESORBABLE | INSERTION OF A NEW CODE | |
| X0304 | SUBSTANCES, COMBINATIONS OF SUBSTANCES, OR ITEMS WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED FOR FACIAL OR OTHER DERMAL OR MUCOUS MEMBRANE FILLING BY SUBCUTANEOUS, SUBMUCOUS OR INTRADERMAL INJECTION OR OTHER INTRODUCTION, BY A PREFILLED MEANS FOR INTRODUCTION, EXCLUDING THOSE FOR TATTOOING – NON RESORBABLE | INSERTION OF A NEW CODE | |
| X0401 | EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOSUCTION | INSERTION OF A NEW CODE | |
| X0402 | EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOLYSIS | INSERTION OF A NEW CODE | |
| X0403 | EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE FOR LIPOPLASTY, OTHER THAN LIPOSUCTION OR LIPOLYSIS | INSERTION OF A NEW CODE | |
| X0501 | HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – LASER | INSERTION OF A NEW CODE | |
| X0502 | HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – INTENSE PULSED LIGHT | INSERTION OF A NEW CODE | |
| X0599 | HIGH INTENSITY ELECTROMAGNETIC RADIATION EMITTING EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR USE ON THE HUMAN BODY, FOR SKIN RESURFACING, TATTOO OR HAIR REMOVAL OR OTHER SKIN TREATMENT – OTHER | INSERTION OF A NEW CODE | |
| X06 | EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED FOR BRAIN STIMULATION THAT APPLY ELECTRICAL CURRENTS OR MAGNETIC OR ELECTROMAGNETIC FIELDS THAT PENETRATE THE CRANIUM TO MODIFY NEURONAL ACTIVITY IN THE BRAIN | INSERTION OF A NEW CODE | |
| Y120615 | POWER ASSISTED MOBILITY ROLLATORS | INSERTION OF A NEW CODE | |
| Z120601 | ELECTROTHERAPY EQUIPMENT | MODIFIED TERM | New term: ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) |
| Z121001 | RADIOFREQUENCY INTRA-CEREBRAL LESION GENERATORS | MODIFIED TERM | New term: RADIOFREQUENCY NERVOUS TISSUE ABLATION INSTRUMENTS |
| Z12101201 | MAGNETOENCEPHALOGRAPHY SYSTEMS | INSERTION OF A NEW CODE | |
| Z12101280 | MAGNETOENCEPHALOGRAPHY INSTRUMENTS – HARDWARE ACCESSORIES | INSERTION OF A NEW CODE | |
| Z12101282 | MAGNETOENCEPHALOGRAPHY INSTRUMENTS – SOFTWARE ACCESSORIES | INSERTION OF A NEW CODE | |
| Z12101285 | MAGNETOENCEPHALOGRAPHY INSTRUMENTS - CONSUMABLES | INSERTION OF A NEW CODE | |
| Z12101292 | MAGNETOENCEPHALOGRAPHY INSTRUMENTS – MEDICAL DEVICE SOFTWARE | INSERTION OF A NEW CODE |
Regulatory Update - 362
In the collection Applicable Requirements, you can now add a Regulatory Focus (for example EU-MDR) to allow sorting and grouping of your requirements. Please be aware that this formfield is NOT displayed in the standard entry view.
Regulatory Update - 361
With this big update we added several standards to the regulatory requirements collection.
EN/IEC/ISO standards and technical reports explicitly related to medical devices
| EN ISO 10993-1:2020 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process |
| ISO 10993-4:2017/Amd 1:2025 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1 |
| EN 62366-1:2015;EN 62366-1:2015/A1:2020 | Medical devices – Part 1: Application of usability engineering to medical devices |
| EN 62304:2006;EN 62304:2006/Cor. Nov:2008;EN 62304:2006/A1:2015; | Medical device software – Software life-cycle processes |
| ISO/TR 80002-2:2017 | Medical device software - Part 2: Validation of software for medical device quality systems |
EN/IEC standards related to medical electrical equipment
| EN 60601-1:2006;EN 60601-1:2006/Cor. Mar:2010;EN 60601-1:2006/A1:2013;EN 60601-1:2006/AC:2014;EN 60601-1:2006/A2:2021;EN 60601-1:2006/AC:2022;EN 60601-1:2006/A13:2024; | Medical electrical equipment – Part 1: General requirements for basic safety and essential performance |
| EN 60601-1-2:2015;EN 60601-1-2:2015/A1:2021 | Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests |
| EN 60601-1-6:2010;EN 60601-1-6:2010/A1:2015;EN 60601-1-6:2010/A2:2021 | Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability |
| IEC/TR 60601-4-5:2021 ED1 | Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications |
| EN IEC 60601-2-39:2025 | Medical electrical equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment |
| IEC 60601-2-16:2025 ED6 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
| IEC 60601-2-68:2025 ED2 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
| EN 62353:2014 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment |
EN/IEC standards related to software, cyber security and general security (not explicitly related to medical devices but in some cases still applicable)
| IEC 29148:2018-11 | Systems and software engineering - Life cycle processes - Requirements engineering |
| EN IEC 81001-5-1:2022 | Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle |
| EN IEC 61340-5-1:2024 | Electrostatics - Part 5-1: Protection of electronic devices from electrostatic phenomena - General requirements |
| EN 82304-1:2017 | Health software - Part 1: General requirements for product safety |
| EN IEC 62443-4-2:2019/AC:2022-09 | Security for industrial automation and control systems - Part 4-2: Technical security requirements for IACS components |
| EN IEC 62443-3-3:2019 | Industrial communication networks - Network and system security - Part 3-3: System security requirements and security levels |
| EN ISO 7010:2020;EN ISO 7010:2020/A1:2020;EN ISO 7010:2020/A2:2022;EN ISO 7010:2020/A3:2022;EN ISO 7010:2020/A4:2023;EN ISO 7010:2020/A5:2023;EN ISO 7010:2020/A6:2023;EN ISO 7010:2020/A7:2024;EN ISO 7010:2020/A8:2024; | Graphical symbols - Safety colours and safety signs - Registered safety signs |