Your company may have done a decent job of making sure your products are compliant with the new and highly anticipated European MDR (Medical Device Regulation), the deadline of which is quickly approaching in May, 2021. But have you addressed all the potential pitfalls: unanticipated reclassification of existing products; surprise audits, sample requests and product testing; and updated labeling requirements, etc.?
Any new submissions will require compliance to the new MDR rather than to the outgoing Medical Device Directive (MDD: 90/385/EEC). Come May 2025, devices listed under the MDD cannot be sold. Published in May 2017, the MDR will replace the existing Medical Device Directive in May 2021. Medical device manufacturers now have less than two months to comply. But what does this mean? It means that not a single medical product can receive market approval in Europe without extensive certification and documentation.
Device manufacturers will need to reclassify their product based on the revised classification rules and update their documents to conform with the new rules. In fact, it is possible for an existing product to be reclassified to a risk class higher than the original. This can be especially true for implantable products.
The documentation for MDR compliance is much more rigorous than previous requirements. Technical documents must be more precise and regularly updated. As a comparison, the MDR features nearly 5 times as many articles as the MDD and 6 times the number of pages!
There is much more oversight by the notified bodies. Notified Bodies now have increased post-market surveillance authority. This will include unannounced audits, sample requests, and product testing. Device manufacturers may be required to perform annual safety and performance reporting. Post-market surveillance was not a focus in the Medical Device Directive. However, it’s an important distinction with MDR compliance. Medical device manufacturers must have documentation proving this post-market surveillance as well as pre-and-post market clinical evaluation.
Updated device labeling is also required. Now the device label must include a Unique Device Identifier (UDI), which includes a device and production identifier in both human readable and machine scannable form. The idea is to allow for a more modern way to perform post-market surveillance, allow for better traceability and recalls, and to help increase overall patient safety.
The MDR is an important step in updating the aging MDD, developed in the 90’s. However, it can be a daunting task as there are many testing and documentation obligations which are very time consuming and very costly to the device manufacturer. This is especially so for the smaller device manufacturers who lack internal resources for such compliance.
Many of the MDR requirements can also extend to the device manufacturer’s component suppliers. Steute Meditech has seen these issues coming for some time and expanded its range of regulatory services, making our products MDR-ready from our ISO 13485 audited company. Steute’s software is tested and documented to DIN EN 62304 (which verifies all functions of the software specification). Risk analysis (risk calculation) was performed and documented to DIN EN ISO 14971. Documentation was created for software and wireless submission, including safety of medical electrical devices to DIN EN 60601-1. Other actions include usability to DIN EN 62366, EMC to DIN EN 60601-2, RED to 2014/53/EC, CB report, FDA 510(k) product documentation, and linking up with the FDA device listing of the device manufacturer. These actions and more allow the device manufacture to focus on their core system and less on the human interface device, saving time and costs!
Sponsored content by Steute Meditech, Inc.