With Brexit happening and rampant spread of the coronavirus affecting global supply chain, meeting the new EU MDR 2020 regulations gets all the more challenging for medical device manufacturers. And, even more daunting will be to become compliant as quickly and efficiently as possible.
With less than couple of months to go before the deadline, the countdown is on for all medical device manufacturers doing business in Europe to ensure they are compliant with the European Union’s Medical Device Regulations (EU MDR), which aims at improving the traceability features & safety management of medical devices for sale/supply across the EU.
Replacing the EU’s current Medical Device Directive (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC), the EU MDR 2020 will come into implementation on 26 May 2020. Global medical devices manufacturers selling/suppling within the EU must strictly adhere to the guidelines, ensuring their products are safe to use in EU.
From 26 May 2020, all medical devices will need to be assigned a Unique Device Identification (UDI) code. Those of which fall under Class III and Class IIa/b will require to have their UDI recorded, indexed, and registered on a central EU database new databases for clinical investigations, product registration, and post-market surveillance called EUDAMED – the European Database for Medical Devices.
All manufacturers of Class III & Class IIa/b products will be responsible for sharing product data according to Annex VI Part B of the EU-MDR regulation. Manufacturers of Class I products will also be required to collect and save product data. They will need to share this information only if requested.
With the introduction of the new EU MDR, the medical device manufacturers will be obligated to invest in technology that shall enable quick & accurate application of traceability coding to products/packaging at an individual item level. Failure to comply with these procedures will bar the device manufacturers from supplying/selling their products to other EU member states along with hefty penalties!
How can Krypt help?
We can help you gain insight into how your supply chain can be integrated using SAP GTS and be EU MDR compliant. Don’t miss the opportunity to attend Krypt’s Webinar – EU MDR with SAP GTS covering following topics:
- Introduction to EU MDR
- Benefits of EU MDR
- Geographical scope
- Supply chain deliverables
Please REGISTER for the webinar and mark your calendar & block your date for April 09, 2020.