In December 2019, the European Parliament approved the second corrigendum of EU MDR. Typically, a corrigendum is comprised of minor corrections to an initial regulation, however that is certainly not the case in this situation. Under this corrigendum, there is a significant impact on certification timelines specifically as it relates to certain Class 1 medical devices.
Now under EU MDR, as explained in Article 5, “a device which is a class I device pursuant to Directive 93/42/EEC (MDD), 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.”
Consequently, certain Class 1 devices (excluding custom-made devices) that meet the criteria described above and would require Notified Body review under EU MDR will have a four-year grace period until May 26, 2024 to be certified to EU MDR. Some of the Class 1 devices potentially impacted by this grace period are reusable surgical instruments, software, substance-based devices, and others.
It is important to note that while this extension impacts certification timelines, it is not a delay in the application of most of the aspects of EU MDR. For example, manufacturers will still need to set up and maintain risk management processes, an effective quality management system (QMS), post-market surveillance (PMS), post-market clinical follow-up (PMCF) procedures, and vigilance in accordance with the EU MDR.
While this delay in certification for certain Class 1 devices is certainly welcomed by many manufacturers, companies must continue diligently with their certification progress and not fall into the trap of relying too heavily on this extension. Keep in mind that there are restrictions with respect to the grace period as explained in the corrigendum that must be carefully considered. In addition, it’s been well-documented that Notified Bodies are struggling to keep pace with the demands of this new regulation, and therefore manufacturers will likely find themselves at the mercy of Notified Bodies’ availability when it comes to certification. Those waiting until the end may find themselves out of luck and trapped in the unenviable position of having to withdraw devices from the market.
A link to the full corrigendum is included here, with English on pages 43-48. https://data.consilium.europa.eu/doc/document/ST-13081-2019-INIT/en/pdf