Even with the delay of the European Union's Medical Device Regulation (MDR) deadline until May 26, 2021, the race to reach compliance is still on for medical device manufacturers. The preparation and implementation processes are still extremely rigorous and time-consuming, and COVID-19 has caused additional strains for Notified Bodies (NB).
Manufacturers need to prepare to navigate these conditions efficiently while readying devices for submission, leaving no room for error. They have to know all the minor ins and outs of the MDR to ensure submissions are compliant and completed on time. There are often overlooked facts to consider when preparing an MDR submission that can help manufacturers minimize risk and pass their submissions with flying colors.
Compliant Data vs. State-of-the-Art
While it is required for companies to submit complete data packages for all devices aiming to remain on the EU market, additional testing may not be necessary to satisfy the expectation that all device evaluations meet current standards as required under the MDR. Regulators will accept tests and evaluations that do not meet current standards if any gaps identified in the tests or evaluations can be justified as meeting MDR requirements. Manufacturers have until May 27, 2024, to comply with this requirement.
The legal formalities of accepting new or revised standards in the EU can be time-consuming and cumbersome. Standards that are legally accepted by all EU countries are referred to as harmonized standards. Device evaluation requirements must meet the expectations set by harmonized standards. Still, regulatory reviewers may expect testing to meet ISO-approved standards that are not yet harmonized to be used in the evaluations because these standards are considered state-of-the-art. The challenge for manufacturers is balancing when to use data that only comply with current harmonized standards and when it is worth the extra time to generate data that will meet the state-of-the-art unharmonized ISO standards.
Broadly, there have not been numerous changes to biocompatibility standards and most of the testing methods are still sound. Some manufacturers can satisfy MDR testing requirements without having to do any additional biocompatibility testing. One area for consideration during submission preparation is the expectation to limit the use of in vivo testing. Unnecessary in vivo testing may place submissions in a negative light for EU regulators. If in vivo testing is necessary for specific devices, it may be beneficial to look into whether past data is still compliant to avoid the need for further testing.
The most significant testing changes are associated with chemical characterization. ISO 10993-18:2020, while not harmonized, now represents the state-of-the-art for...