With the Medical Devices Regulation (MDR) set to become fully applicable next month, the European Commission (Commission) has published an update to its Implementation Rolling Plan (Plan) for both the MDR and the In-Vitro Devices Regulations (IVDR) implementation. Our summary of the key updates to the Plan is set out here.
1. Notified Body designations
Under the MDR and IVDR (together the “Regulations“), the designation of existing Notified Bodies will expire on 26 May 2021. To maintain the ability to continue oversight of medical devices, Notified Bodies must obtain re-designation in line with the requirements of the Regulations.
We previously noted the broadened scope of medical devices subject to compulsory conformity assessments under the Regulations, and the low rate of re-designation of Notified Bodies, has led to justifiable concerns that a device certification bottleneck will result in product shortages.
The Plan does not provide much information to alleviate these concerns, merely stating that Notified Bodies are being designated “on a rolling basis”. At the time of writing, there are 20 Notified Bodies designated under the MDR, with Finland’s Eurofins Expert Services Oy most recently achieving this status. Eight more Bodies are currently in the final stages of review.
Medical device companies are not restricted to obtaining approval from Notified Bodies in the jurisdiction in which they operate. Approved Notified Bodies can apply for conformity assessments in any Member State provided they are authorised to perform assessments on the specific classification of the device at issue.
2. Products without a medical purpose
Certain products without a medical purpose (e.g. liposuction equipment or dermal fillers), which were outside the scope of previous directives, now fall under the remit of the MDR. These are set out in Annex XVI of the MDR. The application of the MDR to such products depends on the adoption of common specifications.
According to the Plan, the Commission expects to adopt an implementing act to give effect to these common specifications in the third quarter of 2021.
The MDR mandated the creation of a European database on medical devices (EUDAMED). This database aims to streamline and facilitate information flow between economic operators, notified bodies, clinical trial sponsors and member states. EUDAMED will be structured around the following six modules:
- Actors registration
- Unique Device Identification registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
Despite being described as “high priority” for the Commission, the Plan records the estimated go-live date for a fully functional EUDAMED as 2022.
4. Standardisation Requests
Finally, the Commission has provided an update regarding standardisation requests. Existing European standards for medical devices need to be revised and new standards developed to reflect the new legislative framework of the MDR.
As emphasised in the Plan, an implementing decision to this effect was rejected last year by the European standardisation organisations, CEN and Cenelec. On 14 April 2021, the Commission adopted an amended implementing decision, requesting CEN and Cenelec to revise the existing harmonised standards and to draft new harmonised standards in support of the MDR. If accepted, the Plan states that implementing decisions with updated harmonised standards will be published periodically in the Official Journal throughout the remainder of 2021.
With just over a month to go until the MDR becomes applicable throughout the EU, much remains on the Commission’s to-do list. Despite transitional measures, manufacturers are facing uncertainty. Device manufacturers should keep a close eye on further updates from the Commission and the HPRA in the coming weeks and months.
If you require further information on any aspect of the MDR or IVDR, please contact Charleen O’Keeffe.
Contributed by Darragh Larkin