The Basics of the European Medical Devices Regulation (EU MDR)
Regulations for medical devices like the European Medical Devices Regulation or in short EU MDR exist since the 90ies, for example the Medical Devices Directive (MDD) 93/42/EEC. Technological and regulatory developments required important updates though. The results are Regulation (EU)2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices”, commonly called Medical Devices Regulation (which repeals the MDD among other things) as well as Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Medical Devices Regulation – what’s new for manufacturers?
Compared to its predecessors, the EU MDR goes a lot further. Among the main changes are:
- New classification and categorization and an extended scope
- More transparency through Unique Device Identification (UDI), traceability and reporting
- Stricter control before product enters the market through a new scrutiny mechanism and mandatory clinical evaluation
Official date of application of the EU MDR is 26 May 2020. The Regulation includes different deadlines for registering in the EUDAMED database, identifying and marking devices etc.
EU MDR: Scope and classification
The EU Medical Devices Regulation does not only cover traditional medical devices but extends to aesthetic devices that present certain characteristics and risk profiles as well i.e. breast implants, contact lenses, or cosmetic laser equipment and also includes relevant software. The EU MDR now contains 22 (before 18) classification rules, meaning that some devices might change class. If multiple rules can apply to the same device, the strictest one shall apply, as per Annex VIII, Chapter II of the Medical Device Regulation.
UDI and Traceability under the Medical Devices Regulation
All medical devices covered by the EU MDR must carry a Unique Device Identifier (UDI) to ensure identification and allow for traceability. The UDI consists of a UDI-DI (Device Identifier – specific to a manufacturer and device) and a UDI-PI (Production Identifier – identifies the unit of device production).
The UDI carrier (machine- and human-readable representation of the UDI) is put on the label or on the device itself and on all higher levels of device packaging. Higher levels do not include shipping containers. The Medical Devices Regulation (MDR) does not specify the UDI carrier (but gives examples) which leaves manufacturers room to choose whichever system works best for a device in question as long as it is readable throughout the intended lifetime and use of the device.
Reporting requirements under the EU MDR
Manufacturers will have to report identifying information and other device data elements to the UDI database. Partly accessible to the public, EUDAMED (European Database on Medical Devices) will provide fast, easy access to relevant regulatory information. EU Competent Authorities will put in information received from manufacturers and Notified Bodies to exchange information with the European Commission. EUDAMED will, among other things, include the UDI database, databases of economic operators, notified bodies, clinical investigation, post-market surveillance etc.
EU MDR Compliance – a word of advice
Complex new requirements and new categorization mean that manufacturers should thoroughly analyze the consequences for their current and future product ranges as different classifications come with different requirements. The earlier manufactures prepare for the European Medical Devices Regulation, the more time will remain for testing and trial and error to ensure timely and complete compliance.