MDCG Guidance Archives - Medical Device Navigator

To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.

Functional Always active

The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.

Preferences

The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.

Statistics

The technical storage or access that is used exclusively for statistical purposes. The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.

Marketing

The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.

MDCG Guidance

Intertek — Usability Engineering for Medical Devices: IEC 62366

Eurofins — Extractables and Leachables Testing for Medical Devices

BSI — Post-Market Surveillance and Vigilance Under EU MDR

SGS — Biocompatibility and Chemical Characterization for Medical Devices

DNV — EU MDR Compliance: Person Responsible for Regulatory Compliance (PRRC)

Dekra — Quality Management System for Medical Devices: ISO 13485:2016

SGS — EU MDR Readiness Guide: Technical Documentation and Common Non-Conformities

TÜV SÜD — EU MDR Compliance: UDI, EUDAMED, and Economic Operator Obligations

TÜV SÜD — Biocompatibility Testing for Medical Devices: ISO 10993 Guide

TÜV SÜD — Cybersecurity for Connected Medical Devices: IEC 81001-5-1

TÜV SÜD — IVDR Transition Guide: From IVDD to EU 2017/746

TÜV Rheinland — Risk Management for Medical Devices: ISO 14971:2019

BSI — MDR Transition Guide for Medical Device Manufacturers

BSI — Clinical Evaluation Under EU MDR: Requirements and Best Practices

BSI — Software as a Medical Device (SaMD) Classification and Certification

EU IVDR — In Vitro Diagnostic Regulation (EU) 2017/746 — Official Full Text

EU MDR — Medical Device Regulation (EU) 2017/745 — Official Full Text

MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of MDR and IVDR

MDCG 2019-7: Guidance on Article 15 – person responsible for regulatory compliance

MDCG 2022-11: Notice to manufacturers to ensure timely MDR/IVDR compliance

MDCG 2021-3: Questions and Answers on Custom-Made Devices

MDCG 2021-25: Application of MDR requirements to legacy devices placed on market prior to 26 May 2021

MDCG 2020-3: Guidance on significant changes regarding transitional provision under Article 120 of MDR

MDCG 2021-5: Guidance on standardisation for medical devices

Medical Device Navigator

Directory

Company

Content