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Medical devices regulatory LINK BASE

COVID-19 Regulatory
MDCG 2022-1 Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices
MDCG 2021-21 Rev.1 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices
EC RECOMMENDATION (EU) 2020/403 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat
EC INFORMATION (2020/C 171/01) Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745
EC INFORMATION (2021/C 8/01) with regard to notified bodies’ audits (MDR / IVDR) performed in the context of quality management system assessment
Press release: (Coronavirus) Commission issues questions and answers to help increase production of safe medical supplies
PPE (Conformity assessment procedures for protective equipment)
Handgel (Guidance on the applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution, etc.))
How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context
MDCG 2021-7 Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
MDCG 2020-17 Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions
Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19

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NOTIFIED BODIES – NANDO
(New Approach Notified and Designated Organisations)
Notified Bodies by Legislation (Medical Devices Regulation (EU) 2017/745)
Notified Bodies by Country
Accreditation Bodies by Country (EA - European co-operation for Accreditation: Multi- and Bilateral Agreement Signatories)
European Commission (EC) Directives/Regulations
Commission Implementing Decision (EU) 2022/6 of 4 January 2022 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, sterilisation of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment
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
COMMISSION IMPLEMENTING REGULATION (EU) 2021/2226 of 14 December 2021 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
Medical Devices Regulation (EU 2017/745) - MDR consolidated version C2
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 (forthcoming legislation)
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
EC Guidance documents
Guidance on regulatory requirements for medical face masks
The European Medical Device Nomenclature (EMDN) - the nomenclature of use in EUDAMED
The CND Nomenclature - background and general principles
MDCG - Medical Device Coordination Group (selection)
(source website)
MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation
MDCG 2021-22 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 2021-20 Instructions for generating CIV-ID for MDR Clinical Investigations
MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system
MDCG 2021-13 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR
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 2021-8 Clinical investigation application/notification documents
MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation
MDCG 2021-5 Guidance on standardisation for medical devices
MDCG 2021-4 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746
MDCG 2021-1 Rev.1 Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional
MDCG 2020-18, MDCG Position Paper on UDI assignment for Spectacle lenses & Ready readers
MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
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 2020-13 Clinical evaluation assessment report template
MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745
MDCG 2020-10/2 Clinical Investigation Summary Safety Report Form v1.0
MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories
MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies
MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies
MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices
MDCG 2020-5 Clinical Evaluation - Equivalence. A guide for manufacturers and notified bodies
MDCG 2020-3 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 2020-2 rev. 1Class I Transitional provisions under Article 120 (3 and 4) – (MDR)
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 rev
MDCG 2019-15 rev.1 Guidance notes for manufacturers of class I medical devices
MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
MDCG 2019-9 Rev. 1 Summary of safety and clinical performance A guide for manufacturers and notified bodies - March 2022
MDCG 2019-8 v2 - Guidance document - Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 on medical devices
MDCG 2019-7 Guidance on article 15 of the MDR and IVDR on a ‘person responsible for regulatory compliance’ (PRRC)
MDCG 2019-5 Registration of legacy devices in EUDAMED
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
MDCG 2019-3 Rev.1 Interpretation of Article 54(2)b (Clinical evaluation consultation procedure for certain class III and class IIb devices)
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
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 2018-1 v3. Guidance on basic UDI-DI and changes to UDI-DI
Borderline and Classification
Helsinki Procedure for borderline and classification under MDR & IVDR
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
IMDRF - International Medical Device Regulators Forum
(source website)

IMDRF technical documents

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/N14 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 information documents 

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)

2.1 Scope, field of application, definition

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

2.2 Essential requirements

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

2.4 Classification of Medical Devices

MEDDEV 2.4/1 rev.9 Classification of Medical Devices

2.5 Conformity assessment procedure

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

2.7 Clinical investigation, clinical evaluation

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

2.10 Notified bodies

MDCG 2022-4 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
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”)

2.12 Post-Market surveillance

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

2.13 Transitional period

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

2.14 In-vitro Diagnostic (IVD) Medical Devices

MDCG 2022-3 Verification of manufactured class D IVDs by notified bodies
MDCG 2020-16 Rev.1 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
MDCG 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)
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)

2.15 Other guidance

MEDDEV 2.15 rev.3 Committees/Working Groups contributing to the implementation of the Medical Device
Unique Device Identification (UDI) System under the EU medical devices Regulations 2017/745 and 2017/746
Factsheet for Class I - Medical Devices

FAQ

Is your software a Medical Device?
Questions and Answers on Custom-Made Devices (MDCG 2021-3)
FAQ on the European Medical Device Nomenclature (EMDN)

OTHER TOPICS

MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
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 DOCUMENTS

NBM-003-19 Joint NB-Position Paper on Spinal Classification per the MDR

Updated: April 30, 2022.

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