Certain reusable Class I medical devices may have four more years to apply for conformity approval under the European Union’s Medical Device Regulation (MDR), according to a new corrections document, known as a corrigendum.
Section 120(3) of this second corrigendum proposes that devices designated Class I under 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…” (The English version of this corrigendum begins on page 44.)
As a whole, EU MDR is scheduled to go into effect on May 26, 2020.
Most devices fall under Directive 93/42/EEC, part of the EU’s existing Medical Device Directive (MDD). The MDD includes two segments of Class I devices: low-risk devices that are provided non-sterile or do not have a measuring function; and low- to medium-risk devices that are provided sterile and/or have a measuring function. The MDR adds reusable surgical instruments to the second group, categorizing them as Class I reusable surgical instruments, according to Emergo by UL.
Article 120(3) also points out that MDR requirements for post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in Directive 90/385/EEC or Directive 93/42/EEC, according to an article by the Regulatory Affairs Professional Society (RAPS).
The corrigendum proposes subtracting one day from the period in which devices lawfully placed on the market pursuant to the device directives before May 26, 2020 may continue to be made available on the market or put into service until May 26, 2025, not May 27, 2025.
The second corrigendum includes more minor edits, corrections and additions to Article 78(8), Article 84, Article 88(1), Article 120(8), Article 122, Annex I and Annex III, according to RAPS. The corrigendum must be adopted by the European Parliament to take effect.