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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 technical documents

IMDRF - International Medical Device Regulators Forum

(source website)

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 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)

Guidance MEDDEVs (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

Guidance MEDDEVs (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

Guidance MEDDEVs

(Classification of Medical Devices)

MEDDEV 2.4/1 rev.9 Classification of Medical Devices

Guidance MEDDEVs

(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

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”)

Guidance MEDDEVs

(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

Guidance MEDDEVs (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

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 DOCUMENTS

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

Updated: November 14, 2024.

Naslov

RegulaBase

NOTIFIED BODIES – NANDO

(New Approach Notified and Designated Organisations)

European Commission (EC) Directives/Regulations

MDCG - Medical Device Coordination Group (selection)

Annex XVI products

Borderline and Classification

Class I Devices

Clinical investigation and evaluation

European Medical Device Nomenclature (EMDN)

Implant cards

In-house devices

Authorised Representatives, Importers, Distributors

In Vitro Diagnostic medical devices (IVD)

New technologies

Notified bodies

Person responsible for regulatory compliance (PRRC)

Post-Market Surveillance and Vigilance (PMSV)