A corrigendum is defined as an ‘error to be corrected’. A second corrigendum to the Medical Devices Regulation (MDR) is working its way through the approval process. The first corrigenda, issued in May 2019, made some changes to the technical documentation sampling requirements and other relatively small corrections and adjustments to each of MDR and the In Vitro Diagnostic Regulation (IVDR). Under the MDR, originally there was no transition period for class I devices. The key issue in the second corrigendum is the introduction of a transitional period for class I devices that are classified higher under the MDR than they were under the Medical Devices Directive (MDD) and therefore require the involvement of a notified body. An example is reusable surgical instruments that, under the MDR, require a notified body to assess the aspects related to the reuse of the instruments.
Article 120 of the MDR covers the transitional provisions. The second corrigendum proposes to change this Article. The proposed change allows devices to be placed on the market until 26 May 2024 if, under the MDD, they:
- are class I devices
- have a declaration of conformity drawn up before 26 May 2020
and under the MDR:
- are classified higher
- require the intervention of a notified body
This proposal extends the concept behind the existing provision that valid certificates under the applicable Directives remain valid until their expiry date, or 26 May 2024+, whichever is the earlier. This creates a transition period that allows devices to continue to be placed on the market using these certificates. This provision did not apply to class I devices not requiring notified body certificates under the Directives. A previous blog discussed the validity of such certificates after the date of application of the MDR. There are two provisos to this extension of validity of certificates:
- first, that some requirements of Regulations will apply to devices with valid certificates under the Directives during this transition period. These MDR requirements include those for post-market surveillance, market surveillance by national authorities, vigilance reporting and registration of devices and economic operators
- secondly, that no significant changes are made to the intended purpose or design of the device
These two provisos will also apply to class I devices with declarations of conformity to the MDD covered by the second corrigendum.
This second corrigendum also makes further minor edits, corrections and additions, generally in relation to cross-references, to Article 78(8), Article 84, Article 88(1), Article 120(8), Article 122, Annex I and Annex III.
The corrigendum needs to be adopted by the European Parliament to take effect. It has been discussed and agreed by the relevant committee of the Parliament but needs formal ratification by the full Parliament. A vote of the parliament will only be required if specifically requested. In the absence of such a request, the changes will be considered approved during the plenary session scheduled between 16 and 19 December 2019.
When approved, the changes give more time for transition to manufacturers of class I devices that have a higher classification under the MDR. Such manufacturers need to make sure that they have valid declarations of conformity to the MDD in place before 26 May 2020. These manufacturers should already have plans in place to be in compliance with the MDR, but will have an opportunity to review these plans and decide whether to update the priorities in their overall planning for MDR implementation in the light of these changes. Manufacturers should review any changes to their plans with their notified body. For manufacturers who did not need a notified body under the MDD, you need to select your notified body ensuring they have the correct designation for your devices under the MDR.
Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development