No Grandfather Rights in MDR
Does my device require revalidation under the new MDR?
The new European Medical Device Regulation MDR, EU 2017-745, requires recertification of all medical devices. The biggest impact is on Class I and II products, many devices will be re-classified.
This combined with the loss of grandfather rights could mean that your device needs evidence of performance and safety from a capable laboratory. The required evidence applies to performance, safety, usability, and clinical evaluation.
Current certificates issued under the Directives prior to 25 May 2017 will be valid until the date on the certificate (usually up to 5 years from issue).
Certificates issued under the Directives from 25 May 2017 will be valid until 27 May 2024 at the latest. There are transitional provisions in the MDR for notified bodies to issue certificates until 25 May 2020 (25 May 2022 for the IVDR).
1) More devices will require clinical investigation
The biggest impact of the MDR is on Class I and II products. Under the MDR, many devices will be re-classified to a higher device class, impacting their clinical data requirements. A clinical evaluation report, previously based on an analysis of literature, might suddenly require clinical investigation and/or post market clinical follow-up. For example, a mobile app transmitting cardiovascular data, previously
Class I now falls under Class IIb. Another example, mechanical heart valve sizers will be moved up not one class but two, from Class I to Class III. Make sure you are informed about the new classifications and corresponding clinical requirements of your products.
2) Equivalence will be harder to demonstrate
Traditionally, device companies have been able to use clinical data of an equivalent device for its registration. This has saved the industry billions of euros in replicating clinical studies. Fortunately, this principle does not change under the MDR. However, the bar on equivalence criteria is raised. Devices need to be equivalent with respect to technical, biological and clinical properties. In addition, the manufacturer needs to demonstrate it has access to the equivalent device data, which significantly limits its usability. These criteria were also added in the most recent revision of the guidance on the clinical evaluation (MEDDEV 2.7.1 rev. 4). When data-demonstrating equivalence is not available, clinical investigation is necessary.
3) Device studies should demonstrate clinical benefit
Where medical device clinical studies previously aimed to demonstrate safety and performance, studies under the MDR will now also need to show the clinical benefit to patients. This means that clinical trials should be designed with completely different end-points, more complex study setups, and potentially larger sample sizes. Additionally, clinical investigation plans should include details on prevention of scientific bias. For example, randomization, independent monitoring/auditing, power, objective endpoints, etc.
4) More focus on post-market surveillance
While post-market surveillance (PMS) is mentioned in the MDD, its requirements were not clearly defined. The MDR now clearly outlines what is required from manufacturers. A PMS system shall be used to actively gather and analyze data on the quality, performance, and safety of the device throughout its lifetime. The system should be based on a PMS plan and to be outputted in a report. In addition, Class II and III devices should prepare yearly for periodic safety update reports (PSUR) containing the analyses of the PMS data gathered, including data from post-market clinical follow-u
The changes in classifications require clinical investigation for a greater range of devices. Information on clinical equivalence can still be applied (in many cases), but it may need support with laboratory testing. Technical and biological equivalence is also required. If equivalence cannot be shown clinical investigation is required including the demonstration of the benefits.
MET’s physical laboratory service can be used to validate the performance and equivalence of products, whilst our chemical analysis lab can be used to demonstrate safety. Under the new edition of ISO 10993 is it likely that chemical analysis will provide sufficient additional evidence in most cases.