PREVENTING THE BIG SCARE WHEN YOUR NEXT CLINICAL EVALUATION IS DUE: THE HIDDEN WAKE-UP CALLS FOR LEGACY MEDICAL DEVICES.

How do you keep your legacy medical devices CE marked once the Medical Device Regulation (MDR) applies in May 2021? Can you continue to do what you did under MDD and are you then OK?

A month ago, the Medical Device Coordination Group (MDCG) released a guide with the “how to’s” in MDCG 2020-6, a document that chaotically states when, how and where to find sufficient clinical evidence for legacy devices – without really explaining what is sufficient.

The first wake-up call came on page 9:

“During the period of validity of the MDD/AIMDD certificates, the MDR requirements for the PMS apply from the MDR date of application. Legacy devices are therefore not exempted from the additional requirements in MDR concerning PMS, including PMCF. PMS data and clinical evaluation plans and reports need to be produced and updated”

In other words: No matter when your devices received CE mark, no matter when your CE certificate is up for renewal, on May 26, 2021, all your PMS activities including post-market clinical follow-up (PMCF) have to satisfy additional requirements for the MDR, and all your clinical evaluation plan(s) (CEP) need to be created or updated so that when the next report (CER) is due, you can show conformity to the MDR.

The fundamental idea behind clinical evaluations has always been that the manufacturer of a medical device continuously assesses if the clinical benefits for the patient outweigh the risks, on the basis of clinical evidence. This was detailed in Essential Requirements (ER) in the MDD, and these are rephrased, reformulated and regrouped to General Safety and Performance Requirements (GSPR) in the MDR (Annex I).

Under the MDR, the clinical evaluation has to show that a legacy medical device meets the newly phrased GSPRs, and the data you collect with PMS and PMCF activities now should help you to demonstrate conformity to the MDR when your CER update is due.

Unfortunately, there is no 1:1 translation from ERs to GSPRs – you need to do “a gap analysis” or “new analysis” according to MDCG 2020-6, and while doing so, you may potentially stumble upon a need for new or different (post-market) clinical data than previously planned.

As if that is not enough, there is more in the second wake-up call on page 16:

“Devices previously certified under the Directives might not be considered to have sufficient clinical data for certification under the MDR”,

for several reasons including

“MDR has a more explicit definition of what constitutes clinical data, which may remove some data sources previously used”,
“MDR introduces new requirements on the use of equivalence” (and they are much stricter!), or
the device never has been reviewed by a Notified Body before.

In other words: Even if you have a legacy medical device on the market that has been CE marked for a long time, even when the CE mark is still valid until May 2024, and even if you have been doing regular clinical evaluations under MDD, chances are that you end up with a shortage of qualitative clinical data to provide sufficient clinical evidence to demonstrate conformity with the GSPR.

But what is sufficient clinical evidence? MDCG 2020-6 says that sufficient clinical evidence is understood as

“the present result of the qualified assessment which has reached the conclusion that the device is safe and achieves the intended benefits”,

or, in other words, it is still up to the discretion of the clinical evaluation team to decide when the evidence is “good enough”.

But regardless, what will be considered “good enough” collecting clinical data within the context of a PMCF study? Can we still use questionnaires or surveys? Per the MDCG 2020-6 questionnaires are considered an alternative, provided that such questionnaire is

“clinically relevant scientifically sound”,

and that the design as well as the statistics are appropriately justified.

So how to prevent that your medical device suddenly and unintentionally is without CE mark because the notified body doesn’t consider your clinical evidence and/ or PMCF in line with the MDR?

Bottom line, to get ready for your upcoming deadlines:

Identify possible gaps in internal and external clinical data as well as your PMCF efforts in light of the MDR, specifically with the rephrased GSPRs, the stricter MDR definitions for clinical data and appraisal criteria, and PMCF requirements in mind
Create or update, and execute your clinical evaluation and PMCF plans, and ensure that you can
Create or update your clinical evaluation and PMCF reports in line with the MDR as applicable from May 2021 on.

Fortunately, MDCG 2020-6 has practical advice on how to bridge gaps in clinical evidence, particularly in case you are lacking data from clinical investigations. The options depend on the type of legacy device, and as a general rule are stricter for Class III and implantable legacy devices than for Class I, IIa, IIb, or well-established technologies (WET, Class III and implantables). It’s quite a puzzle, albeit one that presents nice opportunities to keep WET legacy device CE-marked at a relatively low effort. And it is one we strongly advise you to start solving now.

If you like help figuring out the options for your legacy device, (re)planning the clinical evaluation, or setting up PMCF activities, please send us a private message.

Ines

Enschede, June 15, 2020