EU MDR and IVDR Guidance Documents:
A Complete List (Including PDF Download Links)
Last Update: April 1, 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 medical device and IVD manufacturers. To keep the list manageable, we have excluded guidance that is device-specific, intended for Notified Bodies, or deemed minor/esoteric. You can view the entire guidance list here, but the user-friendly version is shown below.
NEW! Released in the last 90 days
- MAR 2021 (Infographic) Is your software a medical device?
- MAR 2021 (MDCG 2020-3) Q&A on Custom Made Devices
- FEB 2021 [MDCG 2021-1] Guidance on best practices until all modules of EUDAMED are functional
Guidance by topic…
Clinical investigations and evaluation
- JUL2020 [MDCG 2020-13] – Medical device clinical evaluation assessment report template
- MAY2020 [MDCG 2020-10] – Safety reporting and clinical investigations
- APR2020 [MDCG 2020-8] – Medical device PMCF evaluation report template
- APR2020 [MDCG 2020-7] – Medical device PMCF plan template
- APR2020 [MDCG 2020-6] – Gathering sufficient clinical evidence for legacy devices
- APR2020 [MDCG 2020-5] – Medical device equivalence in clinical evaluation
- AUG2019 [MDCG 2019-9] – Summary of safety and clinical performance
Unique device identification (UDI)
- JUN2020 [MDCG 2018-3 V1] – Guidance on UDI for systems and procedure packs
- MAR2020 [MDCG 2018-1 V3] – Guidance on basic UDI-DI and changes to UDI-DI
- FEB2019 [MDCG 2019-2] – Application of UDI to combination devices noted in MDR Article 1(8, 9, 10)
- OCT2018 [MDCG 2018-6] – Clarification of UDI responsibilities for Economic Operators
- OCT2018 [MDCG 2018-5] – UDI assignment to medical device software
- OCT2018 [MDCG 2018-4] – UDI core elements for systems or procedure packs
- FEB 2021 [MDCG 2021-1] – Guidance on best practices until all modules of EUDAMED are functional
- JAN2020 [PDF] – Understanding the structure of EUDAMED (see p4)
- APR2019 [MDCG 2019-5] – Registration of legacy devices in EUDAMED
- APR2019 [MDCG 2019-4] – Clarification on registration timelines for devices in EUDAMED
Software and cybersecurity
- JUL2020 – [MDCG 2019-16 V1] – Cybersecurity of medical devices
- MAR2020 [MDCG 2020-1] – Clinical evaluation/performance evaluation of medical device/IVD software
- OCT2019 [MDCG 2019-11] – Qualification and classification of medical device and IVD software
In the pipeline…
There are many guidance documents being developed by the Medical Device Coordination Group (MDCG). In December 2020 the MDCG updated their master list of guidance documents in the works. Many documents that were previously expected to be released in 2020 have been bumped to 2021.
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.