To date, the Medical Device Coordination Group (MDCG) has released over 30 guidance documents for the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). Most of the published guidance documents are aimed towards UDI and Notified Bodies, but what’s the status of guidance for clinical topics like Clinical Investigations and Evaluations (CIE), and Post-Market Clinical Follow-Up (PMCF)?
What is the Medical Device Coordination Group?
The MDCG is a group of members and experts from all of the 28 EU member states, along with observers from third-party countries (e.g. Switzerland, Norway, Iceland) and industry trade and business associations.
The MDCG’s role is to assist the EU Commission in the implementation of the MDR and IVDR. The MDCG provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonized implementation of the new medical device regulations.
One of the MDCG’s primary tasks is to guide the industry on how to understand and implement the requirements of the regulations. The MDCG does so by developing legally non-binding guidance documents, which are published on the EU Commission MDR/IVDR Guidance website.
Since February 2018, the MDCG has published 37 guidance documents that span seven different areas.
- UDI (9)
- EUDAMED (2)
- European Medical Device Nomenclature (2)
- Notified Bodies (16)
- Clinical Investigation and Evaluation (1)
- New Technologies (2)
- Other Topics & Guidance Documents (5)
Most notably, the area of Notified Bodies under the MDR/IVDR has been of high importance, whereas clinical related documents have lacked behind with only one guidance available.
Why is this, and when can the industry expect further guidance on CIE?
Currently available clinical guidance
With only one published guidance for CIE, medical device manufacturers have been forced to revise clinical strategies under the MDR, relying solely on legislative text from the regulation.
The MDCG probably placed more focus on guidance documents for the Notified Bodies (NBs) in the beginning, in the hope that it would speed up the designation of new NBs under the MDR. However, one can question if this has been successful.
In August 2019, the MDCG published its first guidance for CIE, namely guidance on the summary of safety and clinical performance (SSCP). SSCP is directed towards implantable and class III devices, and thus only useful for those device classifications.
For the rest of the industry though, people still await answers and guidance on clinically relevant topics, such as
- What is sufficient clinical evidence?
- How to design a post-market clinical follow-up strategy?
- How does equivalence fit with a clinical evaluation under the MDR?
With that said, the MDCG is, however, working on developing further guidance documents for CIE. But when can we expect these to be available?
Upcoming guidance for CIE in 2020
The MDCG regularly publishes an overview of the ongoing guidance documents. The purpose of this is to keep the industry informed of the ongoing work in the MDCG.
In mid-December 2019, the MDCG published the latest update on the ongoing guidance development plan and in this update, the most awaited clinical related guidance documents had all been delayed to 2020, i.e.:
- Clinical Evaluation – Equivalence
- Clinical evidence needed for legacy medical devices
- Clinical evaluation assessment report template
- Post-Market Clinical Follow-up Plan template
The former is currently under extended consultation, which means they will probably be released sooner than the others. While the latter still await consultation from the Notified Bodies Oversight working group (NBO) and the working group on Post-market surveillance and vigilance (PMSV).
From this information, it’s difficult to say if these guidance documents will be released in early or late 2020. But knowing that all four are either underway or on its way towards extended consultation, must be positive.
Other CIE documents have been forwarded to the EUDAMED CIE group for further development/assessment. But because EUDAMED has been delayed, we may expect a longer time until these will be made available.
… the CI [clinical investigation] module will be the second last developed. Lots of analysis yet to be completed. So I would not expect anything major or concrete on the clinical investigation or the PMS modules before Q4 2020 at the earliest.Richard Houlihan – CEO of Eudamed.eu
Even though the documents listed in the upcoming development plan look promising, it doesn’t necessarily mean that the list is final.
What to expect next from the MDCG
As many companies prepare themselves for a new era of clinical requirements under the MDR, a long waited PMCF plan template will undoubtfully come in handy.
It’s difficult to say when the industry can expect further guidance documents. But it looks like the focus of the MDCG has shifted a bit more towards practical guidance material to manufacturers, rather than just the NB’s.
This might indicate that more (and possibly new) guidance documents will be developed and added to the plan for 2020.
For more information on documents, news, and information on medical devices you can take a look at the European Commission’s official website for Medical Devices.
For access to all available MDCG guidance documents, you can look at the guidance section.
If you don’t have the time to wait for a PMCF plan template from the MDCG, you can seek inspiration from the SMART-TRIAL PMCF white paper.