Manufacturers of medical devices and companies that supply them must provide products and services that are both safe and effective.  And today’s mounting list of regulations, medical device compliance is important to the success of every medical device manufacturer. Failing to achieve compliance will compromise your device’s future.  A compliance and certification strategy proves that a vendor truly places a top priority on safety, quality and risk aversion.

 

UDI – Defined

Unique Device Identification (UDI) is a system to mark and identify medical devices (via bar codes) by the labeler (e.g., manufacturer) within the healthcare supply chain. With a deadline of September 2020, Class I manufacturers are facing a much greater challenge than their Class II and Class III counterparts (deadline September-October 2018) which often relied on manual submission methods via data entry or Excel spreadsheet uploads.

MDR – Defined

Europe’s Medical Device Regulation (MDR), brings widespread and complex changes to how medical devices gain and maintain approval across the European Union.  With the intent of enhancing patient safety, key elements of the new MDR include the expansion of the definition of medical devices; enhanced vigilance, market surveillance and traceability measures; and a centralized EU database for the storage of information on medical devices (EUDAMED).  The next deadline for compliance is March 2020.

Complying with UDI & MDR

4 Critical Action Items:

  • Aggregate your internal product master data from multiple sources into a single repository for data validation and submission
  • Create a complete “source of truth” that can be trusted by your healthcare providers and the regulatory agencies!
  • Enrich & validate the product data based on the FDA-specific attributes, code value lists and validation rules
  • Submit your validated data to the GUDID using FDA approved “Third-Party Submitter” solution

 

Next Steps

The stakes are high on medical device approval. Without approval, you’ll face penalties. And if you stay non-compliant, you’ll compromise your medical device’s ability to reach its market.  Chat with Innovit experts about how we can help you meet these upcoming compliance dates.