RegulaBase

Helsinki Procedure for borderline and classification under MDR & IVDR

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

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

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: December 31, 2021.

Naslov

RegulaBase

Medical devices regulatory LINK BASE

COVID-19 Regulatory

European Commission (EC) Directives/Regulations

EC Guidance documents

MDCG - Medical Device Coordination Group (selection)

Borderline and Classification

IMDRF - International Medical Device Regulators Forum

MEDDEVs - EU Medical devices guidance documents