Late on 25 May 2016, the Council of the European Union issued a press release to announce that the European Commission, the European Parliament and the Council had reached a political agreement concerning the text of the proposed Regulation on medical devices and the proposed Regulation on in vitro diagnostic medical devices. While this step does not constitute the official adoption of the proposed Regulations it indicates that the adoption process will soon be completed with no major changes being anticipated.

Overhaul of the current EU legislation governing medical devices and in vitro diagnostic medical devices

The two Regulations will replace the current Medical Devices Directive1, the Active Implantable Medical Devices Directive2 and the In Vitro Diagnostic Medical Devices Directive3. This will lead to a substantial revision of the current regulation of medical devices and in vitro diagnostic medical devices in the European Union (“EU”).

Although the texts agreed by the Council of the European Union, the European Commission, the European Parliament are not yet publically available, examples of the changes which are expected to be introduced by the Regulations include the following:

  • Additional scrutiny during the conformity assessment procedure for high risk medical devices and in vitro diagnostic medical devices;
  • Strengthening of the clinical data requirements related to medical devices;
  • Strengthening of the designation and monitoring processes governing notified bodies;
  • New classification rules for in vitro diagnostic medical devices;
  • The obligation for manufacturers and authorised representative to have a person responsible for regulatory compliance continuously at their disposal;
  • Authorised representatives would be held legally responsible and liable for defective products placed on the EU market;
  • Increased traceability of medical devices following the introduction of a Unique Device Identification (UDI) system;
  • New rules governing the reprocessing of medical devices;
  • Establishment of EUDAMED III is expected to lead to increased transparency as information from several databases concerning economic operators, CE Certificates of Conformity, conformity assessment, clinical investigations, the UDI system, adverse event reporting and market surveillance would be available to the public.

Next steps

Although a political agreement was reached on 25 May 2016, the Regulations have not yet been officially adopted. A number of steps must still be taken before the publication and application of the Regulations.

In mid-June 2016, the Council of Ministers’ Permanent Representatives Committee is expected to meet to endorse the political agreement of 25 May 2016.

The European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) will also need to agree to the political agreement.

The two Regulations must then be formally adopted by the Council of Ministers and the European Parliament.

It is anticipated that the English version of the Regulations will be made public in August 2016, with the translations of the texts into the 22 other official EU languages being finalised during Autumn 2016. The official versions of the adopted Regulations could, therefore, be published by the end of 2016. In these circumstances, the Regulation on medical devices would be applicable by end 2019 and the Regulation on in vitro diagnostic medical devices by end 2021.