EU MDR and IVDR Guidance Documents:
A Complete List (Including PDF Download Links)

November 18, 2020

Last Update: December 17, 2021

Shown below is a list of EU guidance documents endorsed by the Medical Device Coordination Group (MDCG). These documents are the ones we believe are most relevant to the majority of medical device and IVD manufacturers. To keep the list manageable, we have excluded guidance that is device-specific, COVID-specific, intended for Notified Bodies, or deemed minor/esoteric. You can (and should) view the entire guidance list here, but first scan the user-friendly version below.

NEW! Released in the last few months…

  • DEC 2021 [MDCG 2021-28]Substantial modification of clinical investigation under Medical Device Regulation
  • OCT 2021 [MDCG 2021-26] – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • OCT 2021 [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
  • OCT 2021 [MDCG 2021-24] – Guidance on classification of medical devices
  • SEP 2021 [PDF] – Helsinki Procedure 2021= Exchange of information between medical device competent authorities on borderline and classification cases

Guidance by topic…

Clinical investigations and evaluation

  • DEC 2021 [MDCG 2021-28]Substantial modification of clinical investigation under Medical Device Regulation
  • JUL 2021 [MDCG 2021-20] – Instructions for generating CIV-ID for MDR Clinical Investigations
  • MAY 2021 [MDCG 2021-8] – Clinical investigation notification documents
  • APR 2021 [MDCG 2021-6] – Q&A regarding clinical investigations
  • JUL 2020 [MDCG 2020-13] – Medical device clinical evaluation assessment report template
  • MAY 2020 [MDCG 2020-10] – Safety reporting and clinical investigations
  • APR 2020  [MDCG 2020-8] – Medical device PMCF evaluation report template
  • APR 2020 [MDCG 2020-7] – Medical device PMCF plan template
  • APR 2020 [MDCG 2020-6] – Gathering sufficient clinical evidence for legacy devices
  • APR 2020 [MDCG 2020-5] – Medical device equivalence in clinical evaluation
  • AUG 2019 [MDCG 2019-9] – Summary of safety and clinical performance

Unique device identification (UDI)

  • JUL 2021 [MDCG 2021-19] – Integrating UDI into a QMS
  • APR 2021 [MDCG 2018-1 rev 4] – Basic UDI-DI guidance and changes
  • JUN 2020 [MDCG 2018-3 V1] – Guidance on UDI for systems and procedure packs
  • JUN 2020 [MDCG 2018-1 V3] – Guidance on basic UDI-DI and changes to UDI-DI
  • FEB 2019 [MDCG 2019-2] – Application of UDI to combination devices noted in MDR Article 1(8, 9, 10)
  • OCT 2018 [MDCG 2018-6] – Clarification of UDI responsibilities for Economic Operators
  • OCT 2018 [MDCG 2018-5] – UDI assignment to medical device software
  • OCT 2018 [MDCG 2018-4] – UDI core elements for systems or procedure packs

EUDAMED database

  • JUN 2021 (MDCG 2021-13] – FAQ on EUDAMED registration related to MDR Article 31 and IVDR Article 28
  • MAY 2021 [MDCG 2021-1 rev 1] – Guidance on best practices until all modules of EUDAMED are functional
  • JAN 2020 [PDF] – Understanding the structure of EUDAMED (see p4)
  • APR 2019 [MDCG 2019-5] – Registration of legacy devices in EUDAMED
  • APR 2019 [MDCG 2019-4] – Clarification on registration timelines for devices in EUDAMED

Software and cybersecurity

  • JUL 2020 [MDCG 2019-16 V1] – Cybersecurity of medical devices
  • MAR 2020 [MDCG 2020-1] – Clinical evaluation/performance evaluation of medical device/IVD software
  • OCT 2019 [MDCG 2019-11] – Qualification and classification of medical device and IVD software

General Medical Device and IVD Guidance

  • OCT 2021 [MDCG 2021-26] – Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
  • OCT 2021 [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
  • OCT 2021 [MDCG 2021-24] – Guidance on classification of medical devices
  • SEP 2021 [PDF] – Helsinki Procedure 2021= Exchange of information between medical device competent authorities on borderline and classification cases
  • AUG 2021 [MDCG 2021-23] – Guidance for notified bodies, distributors and importers on Article 16(4)
  • AUG 2021 [MDCG 2021-22]– Need for expert review of PER for Class D IVDs
  • APR 2021 [MDCG 2021-4] – IVDR transitional provisions for Class D IVDs
  • APR 2021 [MDCG 2021-5] – Guidance on standardization of medical devices
  • MAR 2021 [Infographic] – Is your software a medical device?
  • MAR 2021 [MDCG 2020-3] – Q&A on custom made devices

In the pipeline…

There are many guidance documents being developed by the Medical Device Coordination Group (MDCG). In October 2021, the MDCG updated their master list of guidance documents in the works.

Need help navigating the EU MDR or IVDR?

It’s one thing to download and read all these guidance documents, and quite another to properly apply them. If you need assistance with MDR or IVDR compliance, we are ready to help in any way possible, including our highly popular MDR auditor and IVDR auditor training classes.

Our team is here to help. Call 1.800.472.6477 or contact us online ›