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

November 18, 2020

Last Update: November 23, 2020

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 very minor/esoteric. As you can see, not much has been published lately (most likely due to COVID), which is more than a little concerning given that the MDR takes hold in May 2021. You can view the entire guidance list here, but the user-friendly version is shown below.

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NEW! Released in the last 90 days

  • NOV2020 [MDCG 2020-16] – Guidance on classification rules for IVDs

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

EUDAMED database

  • 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…

Here’s a list of guidance documents by the Medical Device Coordination Group (MDCG) that are in the works. Some just entered the pipeline while others are (supposedly) about to emerge. Again, we excluded product-specific and Notified Body guidance.

Expected by end of 2020 (we’ll see…):

  • Medical device Q&A related to clinical investigations
  • Classification of medical devices
  • Q&A on custom-made and adaptable devices
  • Role of the Person Responsible for Regulatory Compliance (PRRC) (updated)
  • Role of the Authorized Representative (updated)
  • Guidelines on relabeling and repackaging
  • Legal status of app providers
  • EUDAMED harmonized practices and alternative technical solutions
  • UDI integration into manufacturers’ QMS
  • Adaptation of Annexes to IMDRF N48 UDI system application guide
  • Rules and process for update of EMDN
  • 1st release of EMDN

Expected in 2021:

  • Borderline with medicinal products
  • IVD performance evaluation
  • Transfer of Common Technical Specifications (IVDD) to Common Specifications (IVDR)
  • Rules for allocation of EMDN to UDI-DI
  • Procedures for the annual and ad hoc updates of EMDN
  • Common Specifications for devices listed in Annex XVI

Release date TBD:

  • Medical device and IVD postmarket surveillance requirements
  • Medical device and IVD vigilance requirements
  • Medical device and IVD harmonized incident reporting forms
  • In-house manufacturers
  • Artificial intelligence under MDR/IVDR framework
  • SSP (summary of safety & performance) template and guidance
  • Mapping EMDN-GMDN package
  • Translation of EMDN

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 ›