Implementing Medical Device Regulation - COCIR Half-Time Assessment
Date
13 Dec 2018
Sections
Health & Consumers
26 May 2020 is rapidly approaching; with a further 18 months to go, we are now at the midpoint for the implementation of the Medical Device Regulation. The European Commission recently published their implementing measures rolling plan for the Medical Device Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR)1, following the publication of the CAMD roadmap2 last year. This makes it an appropriate time to assess where we stand in the implementation and map the way forward.
COCIR published its recommendations for implementing the MDR at the beginning of this year based on these initial recommendations, we offer this follow-up assessment. COCIR is currently active in all relevant sub-groups and task forces of the MDR. We are increasingly concerned that secondary legislation, including implementing acts, guidance documents and Harmonised Standards, will not be ready on time to allow industry to prepare and diligently implement the Regulation.
COCIR members are at the forefront of innovation, including the digitisation of the healthcare sector. The innovative medical devices they offer make the delivery of healthcare safer, more efficient and more effective. Delays in implementation, the addition of requirements in guidance and uncertainties over the interpretation of the MDR provisions could create a situation where the European Union becomes a less attractive region for investment by medical device manufacturers, in comparison with other leading economies and markets.
ADVERSE IMPACT ON SOCIETY
- Delays in patient access, whereby patients with life-threatening diseases would have to wait for the re-approval and re-authorisation of diagnostic and treatment devices that are currently certified and where patient safety is assured.
- Increasing costs and delays for hospitals accessing the most advanced and efficient medical devices.
- Unnecessary ethical complications arising from clinical investigations, e.g. for devices that have a decades-long safety record
ADVERSE IMPACT ON INDUSTRY
- Adding to the administrative burden and increasing time-to-market that might lead to some innovative medical devices not reaching the European market.
To ensure a successful implementation of the Regulation, COCIR makes the following recommendations to European Commission and EU Member States:
1. Ensure sufficient availability and capacity of NOTIFIED BODIES as well as a European contingency plan for manufacturers that lose their Notified Body. Commission and
Competent Authorities should harmonise their interpretation of MDR requirements in order to avoid lengthy designation procedures.
2. Issue the standardisation request as early as possible, harmonise the NECESSARY STANDARDS on time, and regularly publish the references in the Official Journal.
3. Avoid unnecessary up-classification of MEDICAL SOFTWARE and ensure that provisions for clinical evaluation and investigations are fit for purpose.
4. Provide a clear interpretation of significant change, including the possibility of changing an MDD certificate, during the ‘GRACE PERIOD’.
5. Continue efforts regarding global coherence of UNIQUE DEVICE IDENTIFICATION (UDI) requirements.
6. Ensure timely functioning of the European Medical Device Database EUDAMED allowing actors to access and manufacturers to upload the necessary data, including machine-tomachine functionality. This includes timely availability of specifications for implementation by industry, Competent Authorities and Notified Bodies.
7. Provide clear and timely guidance for CLINICAL EVALUATION of IIa and IIb devices.
8. Finalise the necessary guidance, templates and forms for POST MARKET SURVEILLANCE AND VIGILANCE.
9. Allow pragmatic cooperation for CE marking verification and incident reporting between ECONOMIC OPERATORS.