EU Medical Devices Regulation – Class I products granted deadline extension in new Corrigendum

This marks the second time European institutions take the Corrigendum route to amend the new European Union (EU) legislation on medical devices.

During parliamentary sessions, representatives described the initiative as a "first time in history" and a "procedural disruption", stressing that Corrigenda are intended to correct technicalities and inconsistencies after interinstitutional negotiations ("trialogue") are concluded, whereas the new text proposed by the Council of the EU is set to change the substance of the MDR outside of the established legislative procedure.

Under EU law, Corrigenda to Council acts adopted under the ordinary legislative procedure may only be adopted following a strict procedure, where there are "obvious errors" in the text, including those errors liable to produce undesired legal effects.

In May 2019, a first set of Corrigenda (first Corrigendum to the MDR and first Corrigendum to the IVDR) was published in the Official Journal of the European Union (OJEU). The first Corrigenda mainly sought to amend linguistic errors and minor errors.

The second Corrigenda (second Corrigendum to the MDR and second Corrigendum to the IVDR) were prepared by the Council of the EU. They were adopted as a block by the European Parliament's Committee on Environment, Public Health and Food Safety (ENVI) on 3 December 2019 and, on 17 December, it was announced that both texts were deemed approved, “as there has been no request to put to the vote the corrigenda”.

Impact of the MDR Corrigendum on certain Class I devices

The second Corrigendum to the MDR grants manufacturers of some Class I medical devices more time to seek conformity assessment under the new rules, with significant amendments to the third paragraph of Article 120 of the MDR (entitled "Transitional provisions").

Pursuant to the new Article 120(3):

• a device (a) which is a class I device pursuant to the current Directive 93/42ⁱ, for which the declaration of conformity was drawn up prior to 26 May 2020 and (b) for which the conformity assessment procedure pursuant to the MDR requires the involvement of a notified body; or
• a device which has a certificate (a) that was issued in accordance with the current Directive 90/385ⁱⁱ or Directive 93/42 and (b) that is valid;

may be placed on the market or put into service until 26 May 2024, provided that:

• from 26 May 2020, the device complies with Directive 90/385 or Directive 93/42; and
• there are no "significant changes" in the design and intended purpose of the device.

The new Corrigendum to the MDR will therefore impact economic operators having, in their portfolio, Class I medical devices for which the conformity assessment procedure requires the involvement of a notified body for the first time under the MDR. This is the case, for instance, of devices that are "up-classified" from Class I to Class IIa, Class IIb or Class III under the MDR (eg a large number of software products)  or Class I reusable surgical instruments such as scalpels.

In addition to the conditions set out above, any economic operator should bear in mind that:

• the date of application of the MDR under (26 May 2020) remains unchangedⁱⁱⁱ;
• regardless of the device class, MDR requirements relating to post-market surveillance, market surveillance and vigilance shall apply in place of the corresponding requirements in the Directives from 26 May 2020^iv, while MDR requirements on the registration of economic operators and of devices shall apply subject to Eudamed being operational, once the entire system and its different modules have achieved full functionality and have been subject to an independent audit;
• only those products concerned by the new Article 120(3) may rely on the grace period ending on 26 May 2024.

ⁱ Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
ⁱⁱ Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
ⁱⁱⁱArticle 123(2) of the MDR
^ivArticle 120(3), second sentence, of the MDR