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MEDDEV and MDCG Guidance Documents for MDR CERs Is MEDDEV 2.7/1 Rev. 4 Still Relevant?

Five years ago I wrote about the new MEDDEV 2.7/1 Rev. 4 guidance document for preparing CERs. When that guidance was issued, Notified Bodies widely communicated that while it referred to the MDD, it was written with the upcoming MDR rules in mind. The new MEDDEV guidance served as fair warning for what to expect from the MDR. Now that the MDD is finally gone, and the MDR is fully in place, we’re often asked how much we still rely on the MEDDEV guidance. It’s a fair question, especially since the language in the MEDDEV guidance is specific to MDD and not MDR. And, MDR guidance documents are being issued by the Medical Device Coordination Group (MDCG).

The MDR established the MDCG to develop guidance for manufacturers and Notified Bodies for implementation of the MDR.  The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.  The guidance documents they’ve produced so far, found at https://ec.europa.eu/health/md_sector/new_regulations/guidance_en, are like the MEDDEV guidance in that they are only quasi-official.  So what does the MDCG say about writing CERs?

  • MDCG 2020-5 discusses the use of equivalent devices in clinical evaluations under MDR, and how MDR compares to MDD as interpreted by the MEDDEV guidance. This is nice, but the ability to use data on equivalent devices is so restricted under MDR that it is no longer a practical option for most manufacturers in most instances.
  • MDCG 2020-6 provides guidance on clinical evidence needed for legacy devices (those CE marked under MDD) and devices using “well-established technology”. This can be helpful since it includes a list of sections of the MEDDEV guidance that are still relevant to legacy devices.

The MDCG 2020-13 (Clinical Evaluation Assessment Report Template) and MDCG 2020-8 (PMCF Evaluation Report Template) documents also refer to the MEDDEV guidance, mostly in passing. The MDCG website links to a list of many other guidance documents that are in progress, but none appear specific to the preparation of CERs. There doesn’t appear to be a complete MDCG replacement for the MEDDEV guidance on the horizon.

So, the answer to the question is pretty simple; the MEDDEV guidance remains the primary instruction set for preparing CERs. We’ve updated our processes in response to the more stringent clinical evidence requirements and new verbiage of the MDR, and use the MDCG guidance documents as needed. But in the end, the focus is still on having sufficient pre-clinical, pre-market and post-market evidence for device clinical safety and performance.