Will your products be compliant with the European Union (EU) Medical Device Regulation (MDR) when it takes full effect on May 26, 2020? Since the introduction of the EU MDR in 2017, companies in the medical device industry have had a three-year transition period to recertify their products under the new regulation and ensure continued market access.
However, a lack of notified bodies and delays in resource availability have increased the likelihood that companies may not be able to meet the deadline. Industry representatives have also raised concerns over these challenges. According to a recent survey, only 27 percent of medical device manufacturers expect to be fully compliant by the deadline.
If your company has not yet recertified its products under the MDR, there is good news: EU MDR provisions allow manufacturers to ensure medical devices remain available on the market after the deadline.
Obtain CE Certificates From Designated Notified Bodies
The EU MDR legal framework established manufacturers can obtain Conformité Européenne (CE) certification against the new requirements of the regulation. This must be done through an MDR-designated notified body, of which there are only nine, though the European Commission has indicated that 44 existing notified bodies have applied for the designation.
CE certification is a regulatory standard that confirms a product is safe for sale and use in the European Economic Area. There is no single regulatory body that grants CE certification, which means companies are responsible for identifying their requirements and collecting and verifying applicable data, among other tasks. Third-party solutions support companies in obtaining this certification, but a notified body will still need to conduct an independent conformity assessment to ensure a product can stay on the market.
Grace Period for Eligible Devices
Article 120(3) of the MDR allows Medical Device Directive (MDD)-designated notified bodies to renew or extend certificates issued under the MDD. These notified bodies can do so until May 26, 2020, providing a grace period for companies with MDD-certified products. Leveraging existing medical device data helps companies collect the information they need for notified body submissions.
This provision only applies to products that have not received “significant changes,” (Article 120(3) of the EU MDR legal text), but with no official guidance from the European Commission in place, determining what constitutes “significant changes” presents a further challenge. Additionally, three different groups of low-risk Class I medical devices (reusable surgical instruments, devices in sterile conditions and devices that have a measuring function) have been granted an additional four-year grace period, provided they are already fully compliant with the MDD.
The two-year delay of the European Database on Medical Devices (EUDAMED), meanwhile, does not provide any grace periods for compliance. While electronic reporting to the database is not required until 2022, companies in scope of the MDR will still need to meet notified body reporting requirements, though the format and process for this has not yet been defined.
Apply for Time-Limited Derogations
Manufacturers may also apply for time-limited derogations at the national level to ensure products remain available to patients. Once approved nationally, the European Commission could then make these derogations applicable across the EU. Derogations are typically time-limited to a few weeks, but, in theory, could be extended to allow additional time for notified body approval.
These provisions give medical device companies facing the deadline additional options for keeping their products on the market and available to patients, albeit for a limited amount of time. Taking advantage of these provisions will still require significant effort to ensure accurate product data is collected and submitted to notified bodies and other authorities.
Using a robust supply chain data management system such as the Assent Compliance Platform, companies collect and manage the data needed to meet their requirements under a variety of regulations, including restricted substance requirements under Section 10.4 of the EU MDR. Contact us to learn more.