As per the Commission MDR/IVDR Implementation Rolling Plan, we can expect the following Implementing acts in the last quarter of 2020:
- Common specifications for products without a medical purpose [Annex XVI of the MDR]
- Common specifications for IVD Class D
- Setting up of expert laboratories
- Rules to facilitate fulfillment of tasks by the EU reference laboratories and to ensure their compliance with criteria
- Fees for the advice/testing activities performed by the EU reference laboratories services
Date of application for both acts related to the EU reference laboratories cannot be earlier than 25 November 2020 as per the Article 113(d) of the IVDR.
- EUDAMED – Definition of detailed arrangements necessary for the setting up and maintenance of Eudamed – mainly related to support, change management and maintenance rules
The status of all the above acts is ”in planning”.
Please note that the Commission Implementation Rolling Plan is updated on a quarterly basis. Last update released to the public dates from August 2020.