Medical Devices Regulation and in vitro Regulation: Council First-Reading Position, next steps and implementation

Dear Members,

as you may be aware, on 7 March, the Council adopted its much expected First-Reading Position on both the Medical Devices Regulations (MDR) and in vitro diagnostics Regulation (IVDR), bringing the MD and diagnostic community one step closer to the entry into force of the two Regulations.

Shortly after, on 9 March, the EU Commission and CAMD organised their first multi-stakeholder implementation workshop, which EUCOPE attended. The objective was to give the opportunity to all stakeholders to raise expected implementation challenges and priorities, and then discuss “implementation clusters” identified by the EU Commission and the CAMD prior to the workshop. You will find attached a draft document, which served as a basis for discussions. Besides the 7 clusters (scope and classification;), stakeholders requested that important considerations such as non-for-profit training for manufacturers (especially SMEs), governance (transparency and clarity around MDGC) or international convergencebe taken into account during the implementation phase.

Please be informed that the Secretariat will circulate the meeting minutes with the membership, once they’ve been drawn up by the Commission.

On the occasion of the workshop, the audience was also provided with  the expected timeline towards publication in the Official Journal of the EU, and the key derogations to the application dates:

  • 7 March: Adoption of Council’s First-Reading Position on MDR and IVDR
  • 21 March: ENVI vote – European Parliament
  • 4/5 April: Plenary vote – EU Parliament (known as “rapid second-reading”)
  • End of April / early May: Publication of MDR and IVDR in the Official Journal of the EU
  • Publication date + 21 days: Entry into force of MDR and IVDR 
  • Spring 2020: Entry into application of the MDR
  • Spring 2022: Entry into application of the IVDR

The key derogations to the above timeline are:

  • 6 months after entry into force: requirements on Notified Bodies, designation of Competent Authorities and establishment of the Medical Device Coordination Group (MDCG), the main body which will support the Commission in the implementation phase
  • 12 months after entry into force: cooperation among Competent Authorities
  • 18 months after date of application: registration of devices under new Regulations
  • 1-5 years after date of application: placement of UDI-carrier
  • 2 (IVD)/4(MD) years after date of application: maximum period of validity of certificates issued under current Directives
  • 3(IVD)/5(MD) years after date of application: making available of devices placed on the market under current Directives
  • 7 years after date of application: coordinated procedure for clinical investigations.

Finally, the Commission clarified the drafting and adoption process of the 80 Implementing and Delegated Acts (18 mandatory) as following:

  • Implementing Acts (IAs) and Delegated Acts (Das) shall be adopted following a 4-week period for public feedback, as per the Better Regulation Framework
  • For some sensitive Acts, Impact Assessments can be considered, in which case a public consultation will be open for a period of 12 weeks
  • Guidance documents (e.g. MEDDEV) will be adopted only for areas where the Commission is not empowered to provide clarification

The EUCOPE Secretariat will closely monitor the publication of draft Acts on the Commission platform for Better Regulation. Members are strongly encouraged to send their comments to the EUCOPE Secretariat (roulland@eucope.org), which will then submit compiled feedbacks.

In light of the successful meeting, the Commission announced its wish to organise a second workshop before Summer 2017Should you be interested in attending these technical discussions on behalf of EUCOPE, please let me know (roulland@eucope.org).

If you have any questions, feel free to get back to me.

With best wishes,

Delphine

Delphine Roulland | Public Affairs Manager
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)