May Day!…May Day! Medical Device Regulation: Manufacturers of Class I Devices Must Act Now!

As the end of the Medical Device Regulation’s (MDR) transition period approaches, in order to continue trading their products on the EU market, medical device manufacturers are under pressure to ensure that they confirm compliance with the new regulation by 26 May 2020.

Manufacturers of Class I medical devices, which might include non-invasive devices such as stethoscopes, oxygen masks or walking aids, should take particular note of the following issues and obligations which will impact on their ability to keep their products on the EU market beyond May 2020:

1. Manufacturers of products recertified under the Medical Device Directive (MDD) before 25 May 2020 may take advantage of the extended transition period stretching up to May 2024. However, this extension is not available to Class I products, as they have no certificate and have to comply fully with the MDR by May 26, 2020 at the latest.
2. Manufacturers may self-certify their Class I products (only) by updating all technical Information in line with the MDR, including clinical evidence, by May 26, 2020.
3. Alternatively, Manufacturers can update all technical information in accordance with the MDR, to include clinical evidence, and then submit that information / evidence to a Notified Body to review its compliance with MDR by 26 May 2020. However, this is a risky approach given the low number of Notified Bodies currently designated under MDR and the consequent lack of capacity in the regulatory framework.

Irrespective of which route to conformity is selected, all manufacturers must comply with the post-market provisions of the MDR (including PMCF, PMS, PSUR, Vigilance etc.) from 26^th May 2020. Accordingly, for the first time, Class I manufacturers will require a formal Quality Management System (QMS) pursuant to Article 10, paragraph 9 of the MDR.

In light of the issues highlighted above, it is of critical importance that Class I manufacturers allocate sufficient time and resources to demonstrating MDR compliance in advance of the deadline. In addition, in circumstances where a manufacturer’s device is up-classified to Class IIa, IIb or Class III device as a result of the revised classification rules under the MDR, then immediate steps must be taken to engage a Notified Body to ensure that the device is MDR compliant and able to remain on the market.

Regrettably, these tasks will prove more difficult than had previously been anticipated due to the fact that Notified Bodies across Europe currently have severely restricted capacity available to help manufacturers through the process of achieving timely MDR compliance. At the time of writing, just 9 Notified Bodies have been designated under the MDR throughout the EU, compared to 58 Notified Bodies under the Medical Device Directive.

After 26 May 2020, if Class I devices do not conform to new MDR requirements, then they will have to be taken off the market which will in turn impede the ability of manufacturers to gather the necessary clinical evidence in order to file the technical documentation required under the MDR. However, early compliance will enable manufacturers to either use already available post-market clinical data or to perform a post-market study to submit as clinical evidence within the technical documentation required.

In short, Class I manufacturers should immediately turn their attention to EU MDR conformity in order to ensure that their products can remain on the EU market post-MDR and, in case of upward reclassification of Class I products into a higher risk class, ensure that they have enough time to gather and source the required clinical evidence to achieve the all-important CE marking in advance of the deadline.

How we can help

BHSM’s Healthcare and Life Sciences Department offer practical legal and regulatory compliance advice to a variety of clients across the medical devices sector.

For further information on how the introduction of the MDR may affect your business, please contact David Scott in the Healthcare & Life Sciences Department of BHSM on 01 440 8300 / dscott@bhsm.ie.

This article is for general information purposes.  Legal advice must be obtained for individual circumstances.  Whilst every effort has been made to ensure the accuracy of this article, no liability is accepted by the author for any inaccuracies.