With only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020, the Commission has taken various steps towards its implementation. As we have discussed, while there are lots of good intentions, there is still much to be done – although it now seems that a delay to the May date is on the horizon.
Last week, the MDCG published a number of guidance documents providing much needed clarity on some of the “priority” areas. These are set out below, with particular comments on the guidance relevant to the transitional provisions under the MDR.
As part of the implementation process of the MDR, the MDCG is publishing guidance notes on various topics. The guidance notes are not legally binding, but their application is generally expected (much like the MEDDEV guidance under the current system).
Three new MDCG guidance documents have been published so far this month:
- Significant changes: Article 120 of the MDR provides that certain devices that are on the market under the current Medical Devices Directives may continue to be placed on the market after the date of application of the MDR under certain conditions. One of those conditions is that no significant changes in design or intended purpose are made after the date of application of the MDR, i.e. after 26 May 2020. The MDCG’s new guidance on significant changes aims to clarify the changes that would be considered ‘significant’. Examples are given of changes that are, in principle, considered non-significant, which include:
- administrative changes (e.g., change of manufacturer name or legal entity, change of authorised representative)
- relocation/addition of manufacturing site
- certain changes to the quality management system
- changes implemented as a corrective action
Other changes must, however, be assessed for significance on a case-by-case basis using the six flowcharts set out in the guidance, including one on changes to the intended purpose and one on software changes.
The guidance also makes some comments on how such changes should be verified by the notified body as part of the surveillance activities, or following a manufacturer’s submission for prior approval. How this will operate in practice, particularly if there is a disagreement between the manufacturer and notified body as to whether a particular change is significant, is still unclear. However, the guidance notes that “the manufacturer should always remain responsible for providing evidence that all the above-mentioned changes do indeed neither affect the design nor the intended purpose”. In addition, the guidance notes “In relation to class I medical devices requiring the involvement of a notified body for the first time [that are included within the transitional provisions as a result of the recent corrigendum], manufacturers of such devices must be able to justify their decision when the changes are considered to be non-significant. The justification shall be documented and made available when requested”.
- Effect of corrigendum on Class I devices: In an earlier blog post, we discussed the ‘corrigendum’ to the MDR approved in December 2019, and which added certain Class I devices that will be up-classified under the MDR (such as software) to those devices that benefit from the Article 120 transitional period under the MDR. The MDCG’s new guidance on Class I transitional provisions under Article 120 (3 and 4) of the MDR provides procedural guidance concerning the information to be provided by Class I device manufacturers in their Declaration of Conformity under the Directives. Class I products are placed on the market under a self-certification by the manufacturer, and while the guidance does not contain anything particularly surprising for manufacturers, it is a useful confirmation of the rules, including what the authorities and notified bodies will expect the company to be able to evidence if they are relying on this provision.
- Software: The new guidance on clinical evaluation (MDR) / performance evaluation (IVDR) of medical device software complements previously published MDCG guidance on cybersecurity and the qualification and classification of software under the MDR/IVDR.
In addition, two updates to previously endorsed MDCG guidance have also been published this month:
- Guidance document on the Implant Card relating to the application of Article 18 MDR (for background, please see our previous blog post here).
- Guidance on Basic Unique Device Identification – Device Identifier (UDI-DI) and changes to UDI-DI, which complements eight other MDCG guidance notes on UDIs.
To date, 39 MDCG-endorsed guidance notes have been published, out of the 80 or so that are anticipated to be published to clarify the terms of the MDR.