New regulations on medical devices and related standards: ensuring a successful transition 

When: Thursday, 21 September 2017
Where: Brussels - CEN-CENELEC Management Centre
Participation: over 100 persons contributed to the seminar
Presentations: are available via the urls in the seminar programme (pdf format)
Contact: Katerina Kokesova

For whom?

To share their challenges and needs, the seminar targets the stakeholders whose activities are impacted by these new regulations:

  • representatives of Member States Authorities;
  • Notified Bodies;
  • industrial associations and federations;
  • policy makers;
  • societal stakeholders;
  • standardization organizations and their community;
  • and other interested parties.

Why?

The Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDMDR) were adopted on 5 April 2017, replacing the existing Directives. The new Regulations will come into force after the expiration of the transition period, meaning 3 years for MDR and 5 years for IVDMDR.

Over 300 harmonized standards have been developed to support the existing Directives. Under the Regulations, existing harmonized standards will have to be revised and in addition new harmonized standards may need to be developed in order to correspond to the revised essential requirements.

Ensuring a smooth transition will be key to ensure that the stakeholders may benefit from the presumption of conformity granted by cited harmonized standards representing state of the art, and which at the same time advance patient advantages and safety.

What?

Contribute to an intensive one day event with keynotes and panel discussions bringing around the table all relevant stakeholders whose role and cooperation will be crucial for ensuring a successful transition under the new Regulations.

During the event we will:

  • explore the framework under the new Regulations;
  • analyze the impact, priorities and foreseen challenges for the key stakeholders;
  • discuss the compatibility of harmonized standards and common specifications under the new framework;
  • examine the role of harmonized standards under the new Regulations and identify ways in which different stakeholders may contribute to the successful transition;
  • assess the lessons-learnt from the harmonization process under the current Directives.