Medical Devices Regulatory Link Base

Single Market Compliance Space

Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 Decision (EU) 2022/6 of amending Implementing Decision (EU) 2021/1182 as regards harmonised standards Decision (EU) 2021/1182 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council Regulation (EU) 2021/2226 of laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices Council Directive 93/42/EEC concerning medical devices (MDD) Medical Devices Regulation (EU) 2017/745 - MDR Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on medical devices (the dates of application) Regulation (EU) 2020/1207 common specifications for the reprocessing of single-use devices (relevant (EU) 2017/745) In vitro Diagnostic Medical Devices Regulation (EU 2017/746) - IVDR Update - Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) In vitro Diagnostic Medical Devices Directive (98/79/EC) - IVDMD consolidated version M3/C2 Active Implantable Medical Devices Directive (90/385/EEC) - AIMDD consolidated version M4/C1

The CND Nomenclature - background and general principles MDCG - Medical Device Coordination Group (selection) (source website) MDCG 2018-2 Future EU medical device nomenclature - Description of requirements MDCG 2018-1 Rev.4 Guidance on BASIC UDI-DI and changes to UDI-DI

MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products MDCG 2023-5 Guidance on qualification and classification of Annex XVI products Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR

Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v4 MDCG 2022 – 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices MDCG 2021-24 Guidance on classification of medical devices Helsinki Procedure for borderline and classification under MDR & IVDR

MDCG 2020-2 rev. 1Class I Transitional provisions under Article 120 (3 and 4) – (MDR) MDCG 2019-15 rev.1 Guidance notes for manufacturers of class I medical devices

MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED MDCG 2024-10 Clinical evaluation of orphan medical devices MDCG 2024-5 Guidance on the Investigator’s Brochure content Appendix A of the MDCG 2024-5 MMDCG 2024-3 Guidance on content of the Clinical Investigation Plan for clinical investigations of medical device MDCG 2024-3 Appendix A Clinical Investigation Plan Synopsis Template MDCG 2023-7 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalence 2023/C 163/06 Commission Guidance on the content and structure of the summary of the clinical investigation report MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation MDCG 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations MDCG 2021-8 Clinical investigation application/notification documents MMDCG 2021-6 - Rev.1 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation MDCG 2020-13 Clinical evaluation assessment report template MDCG 2020-10/1 Rev 1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 MDCG 2020-10/2 Rev. 1 Appendix: Clinical investigation summary safety report form Guidance on PMCF evaluation report template Guidance on PMCF plan template MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices Background note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation MDCG 2020-5 Guidance on clinical evaluation – Equivalence MDCG 2019-9 Rev.1 Summary of safety and clinical performance A guide for manufacturers and notified bodies

Questions and Answers on Custom-Made Devices (MDCG 2021-3)

MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation(EU) 2017/746 on in vitro diagnostic medical devices) MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional MDCG 2020-15 MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States MDCG 2019-5 Registration of legacy devices in EUDAMED MDCG 2019-4 Timelines for registration of device data elements in EUDAMED

MDCG 2025-3 MEMDN Version History MDCG 2025-2 Summary of EMDN 2024 Submissions and outcome of annual revision MDCG 2025-1 EMDN Ad hoc procedure MDCG 2024-2 Rev.1 Procedures for the updates of the European Medical Device Nomenclature MDCG 2021-12 Rev.1 FAQ on the European Medical Device Nomenclature (EMDN) The CND nomenclature – Background and general principles MDCG 2018-2 Future EU medical device nomenclature Description of requirements The European Medical Device Nomenclature (EMDN)

MDCG 2021-11 Guidance on Implant Card – Device types MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 on medical devices

MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU)2017/746 MDCG 2022-16 Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation(EU)2017/746 on in vitro diagnostic medical devices (IVDR) MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Q&A Obligation to inform in case of interruption or discontinuation of supply MDCG 2024 – 16 Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices MDCG 2024-16 – Annex 1 Device Identification Table

MDCG 2024-4 Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 MDCG 2024-4 Appendix – Performance Study Summary Safety Reporting Form MDCG 2022-9 / Rev.1 Summary of safety and performance Template MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746 MDCG 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746 MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD MDCG 2021-22 Rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 MDCG 2022-10 Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) MDCG 2022-8 Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR MDCG 2022-3 rev.1 Verification of manufactured class D IVDs by notified bodies MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) MDCG 2021-4 Rev. 1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746

MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 MDCG 2025-6 Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) MDCG 2025-4 Guidance on the safe making available of medical device software (MDSW) apps on online platforms MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components Is your software a Medical Device? MDCG 2020-1 Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software MDCG2019-16 rev.1 Guidance on Cybersecurity for medical devices MMDCG 2019-11 rev.1 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR

MDCG 2024-6 Preliminary re-assessment review (PRAR) form template (MDR) MDCG 2024-7 rev. 1 Preliminary assessment review (PAR) form template (MDR) MDCG 2024-8 rev.1 Preliminary assessment review (PAR) form template (IVDR) MDCG 2024-9 Preliminary re-assessment review (PRAR) form template (IVDR) MDCG 2020-3 Rev.1 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD MDCG 2023-2 List of standard fees MDCG 2022-4 Rev 2 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD MDCG 2022-17 MDCG position paper on "hybrid audits" MDCG 2019-6 Rev.5 Questions and answers: Requirements relating to notified bodies MDCG 2022-13 Rev.1 Designation, re-assessment and notification of conformity assessment bodies and notified bodies MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment:guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2021-18 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) MDCG 2021-17 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) MDCG 2021-16 rev.1 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR) MDCG 2021-15 rev.1 Application form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR) MMDCG 2021-14 Explanatory note on IVDR codes MDCG 2020-17 Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions MDCG 2020-14 Guidance for notified bodies on the use of MDSAP audit reports in the context of surveillance audits carried out under the Medical Devices Regulation (MDR)/In Vitro Diagnostic medical devices Regulation (IVDR) MDCG 2020-12 Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues MDCG 2020-11 Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 MDCG 2020-4 Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions MDCG 2019-14 Explanatory note on MDR codes MDCG 2019-13 rev.1 Guidance on sampling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assessment of the technical documentation MDCG 2019-12 Designating authority's final assessment form: Key information (EN) MDCG 2019-10 rev.1 Application of transitional provisions concerning validity of certificates issued in accordance to the directives MDCG 2018-8 Guidance on content of the certificates,voluntary certificate transfers NBOG BPG 2017-2 Best practice guidance on the information required for personnel involved in conformity assessment NBOG F 2017-8 Review of qualification for the authorisation of personnel (IVDR) NBOG F 2017-7 Review of qualification for the authorisation of personnel (MDR)

MDCG 2019-07 Rev.1 Guidance on Article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC)

MDCG 2025-10 Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template MDCG 2024-1-1 DSVG 01 on Cardiac ablation MDCG 2024-1-2 DSVG 02 on Coronary stents MDCG 2024-1-3 DSVG 03 on Cardiac implantable electronic devices (CIEDs) MDCG 2024-1-4 DSVG 04 on Breast implants MDCG 2024-1-5 Guidance on the vigilance system for CE-marked devices DSVG 05 Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence MDCG 2023-3 Rev. 2 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2022-21 Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745

MDCG 2021-5 Rev. 1 Guidance on standardisation for medical devices

MDCG 2025-8 - rev.1 Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles MDCG 2025-7 Rev. 1 MDCG Position Paper: Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles MDCG 2024-14 Rev. 1 Guidance on the implementation of the Master UDI-DI solution for contact lenses MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system MDCG 2021-10 - The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices MDCG 2021-09 Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers MDCG 2018-1 Rev. 4 Guidance on basic UDI-DI and changes to UDI-DI MDCG 2020-18, MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017 MDCG 2019-1 MDCG guiding principles for issuing entities rules on basic UDI-DI MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database MDCG 2018-6 Clarifications of UDI related responsibilities in relation to article 16 MDCG 2018-5 UDI assignment to medical device software MDCG 2018-4 Definitions/descriptions and formats of the UDI core elements for systems or procedure packs MDCG 2018-3 rev 1. Guidance on UDI for systems and procedure packs

Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 MDCG 2022-11 - Rev.1 MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirements Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods rev.2 MDCG 2022-18 ADD.1 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate Addendum 1 MDCG 2022-18 MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 MDCG 2019-3 Rev.1 Interpretation of Article 54(2)b (Clinical evaluation consultation procedure for certain class III and class IIb devices)

MDR/IVDR Language requirements Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country (source website) European Medicines Agency (EMA) Guidance Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) (source website) SCHEER guidelines Update on the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties (source website) CAMD FAQ CAMD MDR/IVDR Transition Subgroup: FAQ – MDR Transitional provisions (source website)

IMDRF - International Medical Device Regulators Forum (source website) IMDRF/AE WG/N43 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes IIMDRF/SaMD WG/N81 Characterization Considerations for Medical Device Software and Software-Specific Risk IMDRF/AIML WG/N88 Good machine learning practice for medical device development: Guiding principles IMDRF/MDCE WG/N65 Post-Market Clinical Follow-Up Studies IMDRF/IVD WG/N64 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification IMDRF MDCE WG/N57 Clinical Investigation IMDRF MDCE WG/N56 Clinical Evaluation IMDRF MDCE WG/N55 Clinical Evidence - Key Definitions and Concepts IMDRF/GRRP WG/N52 Principles of Labelling for Medical Devices and IVD Medical Devices IMDRF/UDI WG/N48 Unique Device Identification system (UDI system) Application Guide IMDRF/GRRP WG/N47 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices IMDRF/PMD WG/N49 Definitions for Personalized Medical Devices IMDRF/NCAR WG/N14FINAL:2023 (Edition 4) Medical Devices: Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form IMDRF/SaMD WG/N41 Software as a Medical Device (SaMD): Clinical Evaluation IMDRF/RPS WG/N19 Common Data Elements for Medical Device Identification IMDRF/SaMD WG/N12 Software as a Medical Device (SaMD): Application of Quality Management System IMDRF/SaMD WG/N12 Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations IMDRF/UDI WG/N7 UDI Guidance: Unique Device Identification (UDI) of Medical Devices IMDRF/SaMD WG/N10 Software as a Medical Device (SaMD): Key Definitions

IMDRF/NCAR WG/N14 FINAL:2025 (Edition 5) Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form" IMDRF/MC/N84 IMDRF Document Implementation Report" Statement regarding Use of ISO 14971:2007 "Medical devices - Application of risk management to medical devices" Statement regarding Use of IEC 62304:2006 "Medical device software - Software life cycle processes" Statement regarding Use of IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance" Statement regarding Use of ISO 10993-1:2009 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Statement regarding Use of ISO 11137-1:2006 "Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices" Statement regarding Use of ISO 14155:2011 "Clinical investigation of medical devices for human subjects – Good clinical practice" Standards WG: Final Report: 'List of international standards recognized by IMDRF management committee members' Current as of: March 2014 Recognised standards MEDDEVs - EU Medical devices guidance documents (source website)

MEDDEV 2.1/1 Definitions of 'medical devices', 'accessory' and 'manufacturer' MEDDEV 2.1/2 rev.2 Field of application of directive 'Active Implantable Medical Devices' MEDDEV 2.1/2.1 Treatment of computers used to program implantable pulse generators (field of AIMD) MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating, as integral part, an ancillary medicinal substance or an ancillary human blood derivative MEDDEV 2.1/4 Interface with other directives –Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment INTERPRETATION DOCUMENT in addition to MEDDEV 2.1/4 MEDDEV 2.1/5 Medical devices with a measuring function MEDDEV 2.1/6 Qualification and classification of stand alone software

MEDDEV 2.2/1 rev.1 Electromagnetic Compatibility (EMC) requirements MEDDEV 2.2/3 rev.3 “Use by”-date MEDDEV 2.2/4 Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

MEDDEV 2.4/1 rev.9 Classification of Medical Devices

MEDDEV 2.5/3 rev.2 Subcontracting quality systems related MEDDEV 2.5/5 rev.3 Translation procedure MEDDEV 2.5/6 rev.1 Homogenous batches (verification of manufacturers' products) MEDDEV 2.5/7 rev.1 Conformity assessment of breast implants MEDDEV 2.5/9 rev.1 Evaluation of medical devices incorporating products containing natural rubber latex MEDDEV 2.5/10 Guideline for Authorised Representatives MEDDEV 2.7/1 rev. 4 Clinical evaluation: a guide for manufacturers and notified bodies under directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD) MEDDEV 2.7/1 rev. 4 Appendix 1: Clinical evaluation on coronary stents MEDDEV 2.7/2 rev. 2 Guidelines for competent authorities for making a validation/assessment of a clinical investigation application under Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD) MEDDEV 2.7/3 rev. 3 Clinical investigations: serious adverse event reporting under Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD) In relation to MEDDEV 2.7/3 rev.3 - Serious Adverse Event (SAE) reporting form (The new SAE reporting form was taken in use by 1 September 2016.) MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies MEDDEV 2.10/2 rev.1 Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices (AIMDD, MDD, IVMD) MEDDEV 2.10/2 rev.1 Attachment 1 - Guidance on the preparation of a curriculum vitae for a Medical Device Expert MEDDEV 2.10/2 rev.1 Attachment 2 - Example of a training course format MEDDEV 2.10/2 rev.1 Attachment 3 - The responsibilities of the Notified Body under the Medical Device Directives Document MEDDEV 2.10/2 rev.1 Attachment 4 - Special Rules of accreditation for Certification Bodies of Quality Systems (scope “Sterile Medical Devices”)

MEDDEV 2.12/1 rev.8 Market surveillance - Guidelines on a Medical Devices Vigilance System MEDDEV 2.12/1 rev.8 - Additional Guidance Regarding the Vigilance System MEDDEV 2.12/2 rev.2 Market surveillance - Post Market Clinical Follow-up studies

MEDDEV 2.13 rev.1 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices(OJ 98/C 242/05) Informative document of the Commission’s services on implementation of directive 2007/47/EC amending directives 90/385/EEC, 93/42/EEC and 98/8/EC MEDDEV 2.14/1 rev.2 Borderline and Classification issues. A guide for manufacturers and notified bodies MEDDEV 2.14/2 rev.1 Research Use Only products MEDDEV 2.14/3 rev.1 Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices MEDDEV 2.14/4 CE marking of blood based in vitro diagnostic medical devices for variant Creutzfeldt-Jakob Disease (vCJD) based on detection of abnormal PrP (host protein) MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device Factsheet for Class I - Medical Devices MDCG 2021-25 Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC TEAM NB (source website) Team-NB Position Paper Implant Card (Team-NB Position Paper on a risk-based approach for medical devices exempted from an implant card and information to be supplied to the patient with an implanted device per Article 18.3)

NB-MED/2.5.2/Rec2 Reporting of design changes and changes of the quality system NB-MED/2.5.1/Rec5 Technical Documentation NBM-003-19 Joint NB-Position Paper on Spinal Classification per the MDR