July 29, 2021

EU MDR PMCF: To Waive or Not to Waive

When is PMCF Required?

When is PMCF Required?  Do “PMCF” if, after proper premarket clinical evaluation, there remains residual risks and/or uncertainty about long-term clinical performance that may impact the benefit/risk ratio. If PMCF is indicated, then be sure the PMCF Plan contains the various design elements prescribed by EU MDR Annex XIV Part B sections 6.1 and 6.2.  Be sure to understand that per EU MDR Annex XIV.6.2(b) and Article 74, the terms “PMCF Study” and “PMCF Investigation” appear to be interchangeable, and mean a specific type of PMCF, namely, a prospective or retrospective post-market clinical investigation.  PMCF “Studies” / “Investigations” need to ensure the high quality of the collected clinical data by following principles of scientific rigor, accuracy, legibility, and completeness.  Refer to MEDDEV 2.12/2 and MDCG 2020-7 for further guidance about those most rigorous types of PMCF.  In contrast, understand also that the term “PMCF” is a general umbrella term for all types of PMCF, thus encompassing clinical investigations (a.k.a., PMCF “Studies”/”Investigations”) as well as other general types of PMCF (such as PMCF based on literature, reactive PMS data, etc.) that aren’t prospective clinical investigations.

The Myth that the EU MDR Doesn’t Allow Waiver of PMCF:

There’s a common myth that the EU MDR doesn’t allow waiver of PMCF.  In truth, we can waive PMCF if the long-term safety and clinical performance are already known from previous use of the device, or where other appropriate post-market surveillance activities would provide sufficient data to address the risks. Prepare a PMCF waiver stating the basis for the decision to waive PMCF and setting a schedule for periodic reconsideration of the waiver.  I still rely on MEDDEV 2.12/2 for further guidance about PMCF waiver.

I would beware of PMS / PMCF systems, assertions, training, or other paradigms that universally demand PMCF for all cases. Such an approach is not in alignment with the EU MDR, and is certain to unnecessarily escalate the cost, complexity, and burden of that aspect of a company’s EU MDR objectives.

To begin with, be sure not to discount that there is longstanding European historical framework and precedent for waiver of PMCF [see MEDDEV 2.12/2 (for the MDD)].  Indeed, I’ve successfully leveraged such waivers repeatedly with NBs under the MDD without objection.

Fast forwarding to the EU MDR era, you may remember my prior Forum explanations of how the EU MDR considers PMCF to be part of PMS.  As covered in my prior Forum posts on the topic and in my white paper “Navigating PMCF and its Mysterious Relationship to PMS and Clinical Evaluation in EU Regulation 2017/745” (email [email protected] for a copy), PMS is always required by the EU MDR, but not PMCF.  Indeed, the EU MDR’s mandatory PMS plan requirements in Annex III.1.1(b) final indent require that the PMS plan contain a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.  This has been echoed by the MDCG in 2020-7 which provides for a manufacturer’s “…justification in relation to non-performance of PMCF…“.

The option for PMCF waiver is clearly and repeatedly stated by the EU MDR, such as:

• Annex II.6.1(d) and Annex III.1.1(b) (applicable to all devices)

• Annex IX.2.1 eighth and ninth indents (available as an option for Annex IX devices, which, by the way, could encompass devices all the way up through class III)].

• Annex VII.4.5.5 directing Notified Bodies (NB) to make way for PMCF waivers during conformity assessments.

• Annex VII.4.6 directing NBs to consider the adequacy of the manufacturer’s PMS plan including a review of the need (or lack thereof) for a PMCF plan.

• In addition is the provision for possible exemption from the need for any clinical data at all(yes you heard me right) in Article 61.10 (born from the same provision in MDD Annex X) which seems by default to, in such cases, waive the need for PMCF. (I actually had a prominent NB once encourage me to pursue that route instead of doing a clinical evaluation based on clinical data!).

Time and again under the EU MDR I’ve continued proving the integrity of these assertions via successful EU MDR third-party conformity assessments of Technical Documentation using PMCF waivers.  So, based on historical MDD conventions along with their reiteration in specific MDR provisions, it seems that the EU MDR clearly intends to maintain the longstanding precedent of permitting PMCF waiver. This is quite sensible in light of the aforesaid unique purpose of PMCF.  Indeed, deploying such a rigorous form of PMS is clearly unnecessary for realizing overall PMS goals for devices where other less-rigorous forms of proactive and reactive PMS would sufficiently guard public health.  I expand further on this topic in my aforesaid white paper.