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.

July 22, 2021

EU MDR Strategy for Configurable Software

 

For my clients that manufacture software-only medical devices, I have sought and implemented what I feel is the ideal:  The software design and architecture are such that there is one executable software file, but that can be configured via licensing to turn various modules on or off.  In this approach, all modules are always present in the software, yet not always turned on.  For the purposes of EU MDR conformity, this means there is one product, and thus one DoC, one NB certificate, and one technical documentation file.  The different licensing configurations are handled in the software and technical documentation via software installation controls.  This approach avoids the hassle of applying the EU MDR’s requirements for “accessories” (i.e., medical devices in their own right), such as the typical need for accessories to have dedicated (usually separate) technical documentation, labeling, DoCs, and/or NB certificates.

 

Noteworthy parts of the EU MDR’s definition [see Article 2(2)] for “accessory” are that a) it’s an article which intrinsically is not itself a medical device [i.e., it’s just a widget that doesn’t intrinsically meet the EU MDR definition in Article 2(1)]; and b) the main software medical device can’t function as intended (i.e., as labeled, advertised, etc.) without the “add-on”.  If the “add-on” doesn’t meet these criteria, then it’s not an “accessory”.  Instead, it would either be part of the main medical device software or else a separate medical device in its own right providing supplemental features/functionality or else or else a non-medical (e.g., an EU MDR preface item 19 general purpose, life-style, well-being, etc.) device all together.  In the approach I’ve modeled above in my first paragraph, all of the software modules and corresponding code, whether turned on or off, are still part of the same software medical device and executable file.

 

If on the other hand the “add-ons” are a) actually add-ons in the truest sense, meaning that they are separated software files/patches/code; and either b1) they actually meet the formal definition of “accessory” [meaning that they don’t intrinsically meet the definition of medical device yet enable the main software medical device to function as intended (rather than just providing supplemental features/functionality)], or b2) they just provide supplemental medical device features/functionality, then the manufacturer would typically be stuck handling such add-ons as “accessories” (i.e., as devices in their own right) or as separate medical devices altogether, where dedicated (typically separate) technical documentation, labeling, DoC, certificates, etc., would be required.

July 22, 2021

EU MDR Changes to MDD DoC under EU MDR Article 120

 

When considering the requirements for revising an MDD (or EU MDR) Declaration of Conformity (DoC) associated with device changes (whether significant or nonsignificant), it’s important to know that there must always be a valid DoC that accurately represents required details about the subject device’s current state of conformity.  Indeed, under the MDD (by way of the EN ISO/IEC 17050 series) and the EU MDR alike, manufacturers are required to continuously update the DoC to assure it remains accurate.

 

Accordingly, if any change is made to an MDD-certified device to be placed on the market after 26 May 2021 [the EU MDR Date of Application (DoA)] under EU MDR Article 120’s transitional provisions, then the subject device’s Declaration of Conformity (DoC) must be revised as needed if the nature of the change impacts the accuracy of the original declaration.

 

As we all know, the MDD and EU MDR both generally require that the Notified Body (NB) be informed about significant changes as part of updating the DoC and technical documentation.  But if the change truly is nonsignificant, then the MDD and EU MDR permit the DoC and technical documentation to be updated without notification to the Notified Body (NB).  That said, be sure to carefully review the NB contract, as some NBs may nonetheless demand to be somehow informed even for nonsignificant changes.

 

Examples of changes that would directly affect the accuracy (and thus require revision) of the DoC include but are not limited to address changes, standard edition changes, part numbers obsoleted, part numbers changed, and others.  Some of these might turn out to be either significant or nonsignificant depending on the associated particulars.  So “be sure you’re sure” about whether the change is significant or nonsignificant.

 

Regarding the clerical aspect (e.g., the form or format) of the revised DoC, it’s noteworthy that the EN ISO/IEC 17050 series has traditionally and normatively given manufacturers the liberty to decide what format suits them best even though it informatively offers an example format.  The EU MDR has not withdrawn such liberty.  Accordingly, to assure DoC accuracy, it seems that manufacturers could either append an amendment (e.g., via memo) pursuant to EN ISO/IEC 17050-1 clause 6.2 or EU MDR Annex IV.9, or else create a new DoC altogether.  I prefer the latter, as the memo-approach seems clunky and ripe for errors and omissions.  Either way, be sure that the expiry date of the DoC remains in alignment with Article 120’s cut-off dates if such changes are made for the context of EU MDR Article 120 transitional provisions.