Dec 4, 2019

On December 3rd, 2019 the European Parliament adopted the second corrigendum of the Medical Devices Regulation (EU) 2017/745 (MDR), with significant compliance deadline implications for some currently self-certified devices.

The full document, including all languages, can be found here. See page 44-49 for details in English. Other languages may have specific issues concerning their translation that are not addressed here.

Although the second corrigendum was adopted in the first voting round in the European Parliament, there is still the possibility Members of Parliament will ask for a plenary vote. Although it is expected that vote will also be positive, it is still possible this proposal will not adopted. Emergo by UL will keep you informed on the outcome of this legal process.

Wider scope for MDR grace period

Most of the corrections are relatively formal corrections in references or numbering. As mentioned in the draft version of the second corrigendum in late November, there is one correction that will have a significant impact on the implementation of the MDR. Article 120.3 will now read (changed details in bold):

By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. 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.

This change means that devices (not custom made devices) that are self-certified Class I under the current Medical Devices Directive 93/42/EEC (MDD) but that will be up-classified under the MDR will not have to be certified to the new Regulation from the Date of Application (May 26th, 2020). Instead, qualifying devices mayrely on the Declaration of Conformity drawn up under the MDD until May 25th 2024. This will impact many self-certified devices:

  • Class I reusable surgical devices;
  • Software, most of which would be up-classified to Class IIa or higher;
  • Many self-certified substance-based devices, of which some would be up-classified as far as Class III;
  • And many others.

However, most MDR requirements will apply; this delay in certification is not a delay in application of the MDR. Therefore manufacturers must still set up quality management systems, procedures for risk management, clinical evaluation procedures and PMS/PMCF procedures, and maintain these procedures.

Make good use of this delay

Many devices will be up-classified. That means there will be more stringent requirements for clinical data of these devices for MDR certification. Clinical data can come from studies or from literature, pertaining to either the subject device or an equivalent device. But clinical data can also come from post-market surveillance (PMS) or post-market clinical follow-up (PMCF) data.

Manufacturers of up-classified devices now have the opportunity to collect real-life data from the use of their devices, and use that information as clinical evidence. It will also help in building routine with drafting Clinical Evaluation Plans, PMS plans, PMCF plans, PMCF evaluation reports, PMS reports and/or Periodic Safety Update Reports(PSUR), even if not all these reports are required yet. Practice makes perfect, so firms should make good use of this opportunity!

No significant changes

Of course this extra delay can only be used if there are no significant changes made in the design and the intended use of a device. The problem here is that this will not be monitored by a Notified Body, whereas such monitoring will occur for devices that rely on MDD certificates. It will be up to the Competent Authorities to oversee these design and intended use change issues. It is not clear if and how Competent Authorities plan to monitor this situation.

Timing of the MDR transition

Manufacturers must time their transition to the MDR carefully. Emergo has seen, and is still seeing, companies that renew their current MDD certificates now. They plan their MDR transition in early 2024. That means that Notified Bodies will be busy then. This may require a “new” manufacturer to make the transition in 2023 or even earlier. This also means that collecting clinical data through PMS and/or PMCF processes is very important, because it increases the chances of a smooth certification.

Additional European MDR an CE Marking information:

  • EU Medical Devices Regulation (MDR) preparation resource center
  • European MEDDEV 2.7.1 rev 4 and Clinical Evaluation Report (CER) consulting
  • On-site EU MDR training for medical device manufacturers
  • Whitepaper: Understanding Europe’s Medical Devices Regulation
  • Whitepaper: PMS and PSUR requirements under the Eu MDR

Author

  • Ronald Boumans

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