Technological advancements in manufacturing make it possible for manufacturers to commercially produce personalized custom medical devices (CMD) much faster. The advancements, when coupled with regulatory changes, can be confusing. That’s why we’ve created this brief review to help clarify the most critical points within recent European Medical Device Regulation (MDR) updates.
MDR Article 2(3) defines CMDs as any device specifically made per a prescription lawfully provided by a qualified professional, with specific design characteristics to address that particular patient’s condition or needs. Mass-produced devices adapted to meet the requirements of any professional user and mass-produced devices per the written prescription or an authorized person are not considered CMDS.
When it comes to considerations and applications of MDR to custom medical devices, manufacturers should ascertain and apply appropriate regulatory requirements and implement a quality management system commensurate to the type and risk of the device being supplied. Our review further explores post-market surveillance obligations and reports, UDI requirements, and adjacent or intermediary products.
Implementing the new MDR requirements and understanding considerations outlined in the MCDG documents for manufacturers of personalized medical devices is complex and may require additional resources and expertise to manage a product through its lifecycle. The article outlines areas that need focus for registration and continuous compliance:
- Regulatory intelligence
- Engagement with health authorities and official agencies on behalf of clients in the EU and abroad
- Medical device call centers and personnel capabilities
- Incident reporting infrastructure
For more details, read the full Review: Questions and Answers on Custom-Made Devices & Considerations on Adaptable Medical Devices & Patient-Matched Medical Devices.