MedTech Europe on CEN/CENELEC Seminar on Standardisation (21 September 2017)

Posted on 28.09.2017

Harmonised standards are a critical part of the EU regulatory system for Medical Devices and IVDs. MedTech Europe welcomes the European Commission’s effort to ensure the harmonisation of standards under both the current Directive and the new Regulations.

The steps presented by the European Commission at CEN/CENELEC Seminar on 21 September included the issuing of a streamlined standardisation request (formerly known as the standardisation mandate) to CEN/CENELEC, based on a priority list of standards that will first undergo harmonisation under the new Regulations.

For MedTech Europe’s members, the horizontal standards applicable for both the Medical Device and IVD sectors, such as those related to labelling, Quality Management Systems and Risk Management would be high priorities for early harmonisation under the new process.

Once this streamlined standardisation request has been implemented, the European Commission intends to issue additional standardisation requests in a timely manner. They will cover:

  1. Alignment of existing harmonised standards (under the Directives) to the new Regulations
  2. Development of new standards in the future, depending on the needs of the new Regulations

The Commission has also outlined the action plan to address the situation of standards that have been proposed to be published in the Official Journal under the Directives but remained in the pipeline for several months. MedTech Europe hopes that this process can start resolving the existing backlog and get the whole standardisation system back on track.

Although the transition periods given for both the MD and IVD Regulations are tight to align hundreds of standards, MedTech Europe is fully committed to giving constructive input, to help make this transition a success.

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