Regulatory Updates 2025
Regulatory Update - 366
Es gibt eine neue Änderung der ISO 15223-1:2021: Amd 1:2025. Die Änderung beinhaltet eine neue Definition des Begriffs „Bevollmächtigter“ und ein geändertes EC REP-Symbol, das nicht mehr länder- oder regionenspezifisch ist.
In der Sammlung Lager- und Transportbedingungen ist das Feld „Lager- und Transportbedingungen“ nun obligatorisch - in der Vergangenheit konnte es zu völlig leeren Einträgen führen.
Regulatorisches Update - 365
In den Sammlung Kontakt Liste können jetzt zwei neue Positionen verwendet werden: PRRC und Business Development Manager.
In der Sammlung Länder & Regionen haben wir die Information „Länder, die mit dieser Region verbunden sind“ hinzugefügt. Wenn man jetzt „Europäische Union“ auswählen, kann man also auch die dazu gehörigen Länder in Dokumenten ausgeben lassen.
Regulatory Update - 364
Die MDCG 2019-6 rev.4 wurde auf MDCG 2019-6 rev.5 aktualisiert.
Die neue Version ist hier zu finden.
Regulatory Update - 363
Mit diesem wiederum recht großen Update haben wir EMDN-Codes entsprechend den in MDCG 2025-2 und MDCG 2025-3 veröffentlichten Änderungen hinzugefügt und geändert.
Bitte beachtet, dass wir die gestrichenen Codes noch nicht herausgenommen haben!
Wir möchten allen Anwendern ausreichend Zeit geben, die Änderungen an diesen Codes zur Kenntnis zu nehmen und ggf. entsprechende Maßnahmen zu ergreifen.
Die folgende Gruppe von Codes wird in einem zukünftigen Update geändert werden:
| 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 |
Die folgenden Codes wurden mit dieser Aktualisierung geändert und sind ab jetzt verfügbar:
| 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 der Sammlung Anwendbare Anforderungen kann man nun einen regulatorischen Fokus (z.B. EU-MDR) hinzufügen, um eine Sortierung und Gruppierung der Anforderungen zu ermöglichen. Bitte beachtet, dass dieses Formularfeld in der Standard-Eingabeansicht NICHT angezeigt wird.
Regulatory Update - 361
Mit diesem großen Update haben wir mehrere Normen in die Sammlung der gesetzlichen Anforderungen aufgenommen.
EN/IEC/ISO-Normen und technische Berichte mit explizitem Bezug zu medizinischen Produkten
| 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-Normen für medizinische elektrische Geräte
| 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-Normen für Software, Cybersicherheit und allgemeine Sicherheit (nicht ausdrücklich auf medizinische Produkte bezogen, aber in einigen Fällen dennoch anwendbar)
| 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 |