[co-author: Eftychia Sideri]
The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”). The roadmap has been prepared in cooperation with the European Commission and it is intended to address the challenges of the MDR and IVDR implementation.
Background information
The MDR and IVDR will be applicable from 26 May 2020 and 26 May 2022 respectively. Medical devices manufacturers, the European Commission, the competent authorities, notified bodies and other stakeholders such as authorised representatives, distributors, importers or standard bodies must immediately start to prepare for the application of the Regulations.
The CAMD has established an MDR/IVDR implementation taskforce with the aim to facilitate cooperation with the medical devices network during the implementation phase of the MDR and IVDR. The CAMD considers that a single European roadmap will help to implement an effective and secure regulatory system and to ensure better protection for public health in the medical devices sector.
The CAMD taskforce now intends to engage with all recommended parties to identify the project plan and deliverable of each priority and continue monitoring progress in relation to the implementation of the MDR and IVDR.
Priorities for Implementation
The roadmap lists seven technical areas/work streams for the implementation of the MDR and IVDR. Additionally, “over-arching and cross cutting” issues are included.
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Clinical Evaluation & Clinical Investigation (MD); Performance Evaluation & Performance Studies (IVD);
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Scope & Classification of MD and IVD;
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Notified Bodies & Conformity Assessment;
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Post-Market Surveillance & Vigilance for both MD and IVD;
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Eudamed & UDI;
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Market Surveillance;
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IVD-specific Issues;
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Over-arching & Cross-cutting Priorities.
The roadmap has assigned a priority rating for every individual working group with each activity. It is also highlighted by the roadmap that although the MDR and IVDR provide for the adoption of specific implementing acts, it is envisaged that additional advance guidance might be needed.
Examples of high priority topics include transitional issues/uncertainties and the risks raised by the Regulations for the continued supply of safe medical devices; the development of guidance document concerning the clinical evaluation or performance evaluation of medical devices and in vitro diagnostic medical devices; the development of Eudamed and reference laboratories for IVD-specific issues.
The document highlights the substantial work which remains to be done to ensure the application of the Regulation by 2020 and 2022.
