- The European Union on Friday released documents specifying data manufacturers will need to include in the European Database on Medical Devices, dubbed Eudamed, for devices and in vitro diagnostics under its new regulations.
- Attributes deemed mandatory for Eudamed under the Medical Device Regulation include, for example: whether the product is a reusable surgical instrument, an active device, or intended to administer or remove a medicinal substance.
- Attributes for IVDs listed as mandatory under the In Vitro Diagnostics Regulation include: whether the device is intended for self-testing, for near-patient-testing, a companion diagnostic, instrument or reagent, or professional testing.
When the European Union adopted its new set of regulations on medical devices and IVDs in 2017, many details remained to be worked out. Those gaps are now being filled as the regulations are phased in. The latest add to guidelines for registering legacy devices and data elements in the database that were released last month by the Medical Device Coordination Group.
The new Medical Device Regulation tightens controls for the safety and performance of medical devices in the European Union, which has cited problems with breast implants and metal hip replacements as one reason for the regulatory overhaul.
The new rules are intended to reflect the technological and scientific advancements in the sector over the past two decades. In addition to establishing the device database, the regulations create an identification system based on a unique device identifier to improve traceability, a patient implant card system, and a financial mechanism to ensure patients are compensated if they receive defective devices.
The rules set out categories of data necessary for submission as either mandatory, mandatory if applicable to the device and optional.
For example, in the category of attributes deemed mandatory if applicable, requirements for class llb implantable devices include noting whether the device is a suture, staple, dental filling, dental brace, tooth crown, screw, wedge plate, wire, pin, clip or connector.
Other mandatory if applicable information includes unit of use, clinical size, and storage and handling conditions.
Attributes for IVDs listed as mandatory if applicable include: direct marking UDI-DI value and issuing entity, unit of use, and storage and handling conditions.