Medical Device Regulation (MDR) European Union (EU) 2017/745 Transition – What is required by the May 2020 deadline?
When does the MDR become applicable?
- The MDR will come into force May 2020.
What does the introduction of the MDR mean?
- The MDR replaces the EU’s existing Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC). The purpose of the MDR is to improve traceability and safety of devices in the EU.
Changes required to transition to MDR:
- Assess Device Classifications
Some device classifications as per the MDD have been retained, while more have become more stringent, which can result in a device being reclassified as a higher class. The MDR has also introduced new rules for software and apps (Rule 11) and new rules for substance-based devices and devices that used hazardous substances.
- Technical File
This will need to be updated to the new MDR requirements.
- Clarify Role of Stakeholders
Economic operators have more responsibility to comply with the MDR, these include manufacturer, importer, distributor and the EU Authorised Representative. These stakeholders are now liable for the product on the market. The new requirements may result in an update/implementation of agreements between parties. The Person Responsible for Regulatory Compliance is also a new requirement, this person needs to be able to demonstrate the necessary expertise through experience and qualification.
- Unique Device Identifier (UDI)
All medical devices must be assigned an UDI code. Class IIa/b and III medical devices will need to have the UDI recorded on the new EU database called EUDAMED.
- Summary of Safety and Clinical Performance
For class III and implantable medical devices, manufacturers must create a summary of safety and clinical performance and this will also be available on EUDAMED.
- Clinical Evaluation / Postmarket Clinical Follow-up (PMCF), Clinical Investigations
The requirements for clinical data have been reinforced in the MDR. This must be planned out in a schedule, the methods for collecting and evaluating clinical data shall be outlined, this will input into post market surveillance as it will be collected throughout the lifecycle of the device.
How to transition?
- Understand the MDR and plan ahead
- Assess your current level of compliance by means of a gap analysis.
- Assess device classification to see if the MDR rules impact current or future products.
- Examine clinical data and clinical evaluation reports, this is under greater scrutiny by Notified Bodies
What happens if you decide not to transition?
Some manufacturers who have existing medical device MDD certificates may not transition before May 2020 and retain their current MDR until expiry, however a significant change to the design or intended purpose of a device after introduction of the MDR may prohibit the manufacturer from continuing to place that device on the market until they are MDR complaint.
KD&A can help you with your transition to MDR or launching a new product which will need to be MDR compliant for supply in the EU. KD&A can perform an in-depth gap analysis of your CE technical documentation, procedures and processes to ensure that the requirements for your organisation are clear.
September 10, 2019