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.