The Impact of EU Medical Device Regulation Deadlines
In May of 2017 the European Union passed its revised Medical Device Regulations (MDR) and InVitro Device Regulations (IVDR). These improved, but much longer, regulations replace the EU’s previous MDD and IVDD directives. The adoption period for medical devices ends 5/26/2021, and for invitro products it ends 5/26/2022.
ALL products with current CE marks under MDD and IVDD must recertify their products under MDR/IVDR when their current certificate expires. If your current CE mark under MDD is issued before 5/26/21, that gives you at maximum until 5/26/2024, or 5/26/25 for an invitro product.
Products that fall under new MDR definitions for Class IIa, IIb, or III that are not currently on the market or CE marked, cannot be sold in the EU after 5/26/21.
Impacts of MDR and IVDR
Currently 70% of medical device companies say they are still not ready for MDR. Without a CE extension, their products may be off the EU market until certified.
Classification has changed. 80% of lower risk Class I devices that could previously be self-certified, are now up-classified as Class II and must be CE marked.
Software as a medical device (SaMD) has increased cybersecurity requirements.
Labeling and IFU’s have new requirements, and a harmonized set of symbols.
Economic operators (importers, distributors, and authorized representatives) must be officed in the EU. They have increased obligations, and must register in the EU’s Database of Medical Devices (EUDAMED).
Clinical and validation testing requirements are much stronger. Data collection for product safety is now similar to that required for a 510K submission to the FDA.
Post market surveillance and monitoring is a much stronger focus, it must be proactive and ongoing. Technical plans, reports and results must remain up to date.
ISO 13485 (which certifies your quality system – not the product) will help. But it doesn’t cover some new MDR regulations around design control, validation, and post market surveillance, which will require some new SOPs.
Only EU Notified bodies can issue MDR product certification (new CE mark). They have new regulations too, and less than half are currently approved. They are swamped, and will be overwhelmed again in 2023/2024 when many current certificates expire. Submitting complete and compliant technical and QMS documents will speed processing and reduce costs for review time.
Suppliers are fair targets for scheduled and unscheduled EU MDR audits (even in the USA), just like tier 2 and 3 suppliers are subject to FDA audits.
Staff training and understanding of their responsibilities under these new requirements is a major source of current MDR audit findings.
Need more info? Go to GreenlightGuru.com for a wealth of detailed transition guidance provided during their recent MDR True Quality Summit.