PMCF plans and the MDR date of application

Do PMCF plans need to be in place as of the date of application of the MDR?

The MDR has identified certain requirements that must be met from the date of application of the MDR, which is now 26 May 2021, just under one year from now. These requirements are listed in the second sentence of Article 120(3), which states:

“However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.”

Thus, post-market surveillance (PMS) requirements must be met from 26 May 2021; however, some companies have questioned whether this also applies to the development of post-market clinical follow-up (PMCF) plans. That is, must these plans also be in place as of the date of application of the MDR? To respond to this question, MDR Chapter VII, Section 1, Post-market surveillance, is relevant. It encompasses the following articles:

• Article 83, Post-market surveillance system of the manufacturer
• Article 84, Post-market surveillance plan
• Article 85, Post-market surveillance report, and
• Article 86, Periodic safety update report

Article 84 states that the PMS system must be based on a PMS plan. The requirements for such a plan are specified in Section 1 of Annex III. According to Section 1(b), the PMS plan must cover a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable. This supports the need to develop an MDR-compliant PMCF plan by the date of application of the MDR, but it is also necessary to evaluate whether the delay in implementation of Eudamed affects the need to develop such a plan. That is, according to the European Commission website, Eudamed will be not be fully functional for medical devices or in vitro diagnostic medical devices before May 2022.

MDR Article 123(3)(d) addresses the delay in Eudamed implementation and its effect on MDR provisions, stating:

“without prejudice to the obligations on the Commission pursuant to Article 34, where, due to circumstances that could not reasonably have been foreseen when drafting the plan referred to in Article 34(1), Eudamed is not fully functional on 26 May 2021, the obligations and requirements that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3).”

The “notice referred to in Article 34(3)” is the publication in the Official Journal of the European Union announcing that Eudamed is fully functional. The text in Article 123(3)(d) above is followed by a list of articles or portions or articles to which this text applies, such as Article 29, Article 31, Article 32 and so on, including the last indent, which is:

-     the second sentence of the first subparagraph of Article 120(3).

The second sentence of the first subparagraph of Article 120(3) is the one noted previously that specifies MDR requirements that must be met by manufacturers with valid certificates or MDD class I declarations of conformity issued under the Directives as of 26 May 2021. The inclusion of this sentence in the list of articles affected by the delay in Eudamed full functionality means that there will be a delay in the implementation of obligations and requirements related to Eudamed for the provisions applicable to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices.

However, requirements unrelated to Eudamed are still applicable to legacy devices that will continue to be placed on the market or put into service under the MDD or AIMDD. This includes the need to develop a PMCF plan alongside a PMS plan, PMS report, and PSUR. These will be required for all devices by 26 May 2021, whether manufacturers use the derogations in Article 120(3) to continue to place legacy devices on the market, or whether they are placing MDR-compliant devices on the market.

Medical device manufacturers now have a little over a year to develop a PMCF plan that meets MDR requirements, unless they plan to comply sooner. Two guidance documents, in the form of templates, have been made available on the European Commission website, one on PMCF plans and the other on PMCF reports. These guidance documents are intended to assist manufacturers in complying with MDR requirements and presenting PMCF plan and report information in a complete and harmonized manner.

Author: Maria E. Donawa, M.D., is President of Donawa Lifescience Consulting, Rome, Italy, a full service CRO in Europe and North America, and provider of in-depth assistance to clients in all aspects of US and European regulatory and quality system requirements for medical devices, including IVD medical devices.