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The Council of the European Union has come to a common position in June on two draft Regulations intended to replace the current Medical Devices Directive: the Active Implantable Medical Devices Directive, and the In Vitro Diagnostic Medical Devices Directive.

This is a milestone of a long legislative process that started back in September 2012, when the European Commission published the two draft regulations, and the European Parliament proposed amendments to the Commission's texts in October 2013. The Council has discussed the Commission proposals since then.

Now, at the19th June meeting, all EU Member States (except Germany and Poland) agreed to validate the amendments prepared by the Council to the original texts of the European Commission. If the proposed Regulations are adopted in their current form, they will lead to an overhaul of the current regulation of medical devices and in vitro diagnostic medical devices in the EU.

Many new provisions would be introduced by the draft Regulations. An outline of some of the most noteworthy proposals concerning the medical devices industry is provided below:

  • The Council has proposed to extend the scope of the Regulation on medical devices to groups of products which are not intended to have a medical purpose.
  • The Council has proposed that the current conformity assessment procedure be strengthened for high risk medical devices.
  • As amended by the Council, reprocessing and further use of single-use devices may take place only when permitted by the EU Member States. The European Commission would also be required to establish and regularly update a list of categories or groups of single-use devices which cannot be reprocessed safely and may, therefore not be reprocessed.
  • Manufacturers of Class III medical devices would be empowered to consult with an expert panel prior to the commencement of a clinical evaluation and/or investigation.
  • The Council has proposed additional responsibilities for the European Authorised Representative appointed by a manufacturer which is not established in the European Economic Area.
  • All manufacturers would be required to appoint a person responsible for regulatory compliance. This person would have the "requisite expertise" in the field of medical devices which may be demonstrated by appropriate qualifications or professional experience in Regulation for medical devices.


The adoption process is will then need a formal agreement on the Council side and trialogue negotiations between the Council, the European Parliament and the European Commission, expected to begin in autumn 2015.

At EFA, we support the European Patients’ Forum (EPF) opinion on the Medical Devices Regulation developments asking the trialogue to ensure that key limitations currently reflected on the proposal are addressed, to ensure the final Regulation provides for safer medical devices in the EU.

More information about EFA’s position on medical devices and current EPF’s opinion visit the following links.

Tags: Category: News
Country: EU
Theme: - Medical Devices