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Manufacturers IVD

Manufacturers IVD

As under the current regulatory regime, manufacturers of in vitro diagnostic medical devices take prime responsibility for getting their products CE-marked for the European market. Now, they need to manage the change to get their products CE-marked under the new Regulation.

The IVDR has the same basic requirements as the previous Directive. It is generally more stringent than the Directive, especially in terms of risk classes and the oversight provided by notified bodies (NBs). There is also more emphasis on a life-cycle approach to safety, backed up by clinical data and post market monitoring (‘vigilance’ and ‘post-market surveillance’).

As a manufacturer you will have to comply with the IVDR by May 2022. It’s important to start the transition as soon as possible. The Regulation allows for transitional provisions if more time is needed due to the

  • high number of devices on the market
  • anticipated bottleneck in reviews by notified bodies
  • ongoing need to interpret certain provisions of the Regulations

An early start is especially important because of the expected pressure on notified bodies during the transition period. Approach your NBs as soon as possible. Check whether they intend to apply for designation under the new Regulation, including the scope they intend to cover, and when they think they will be ready.

Use the information and links below to draw up an action plan and start reviewing the classes your devices fall into under the IVDR.

Key Resources

Related Resources

This is a list of the most recent relevant documents from the Library. For more, filter through our database by clicking on the View More button below.

Release Date : 21 March 2018 | Country : European Union | Language : English

This presentation by the European Commission deals with advisory structures under the new medical devices Regulations, highlighting the functions of eXpert panels and laboratories.

Release Date : 21 March 2018 | Country : European Union | Language : English

This presentation by the European Commission covers EU governance according to the new medical devices Regulations and highlights some of the main features of the new teXts.

Release Date : 14 February 2018 | Country : European Union | Language : English

This document contains data concerning applications by Team-NB member Notified Bodies under the MDR/IVDR and how this compares with their current scope under the three current directives AIMDD/MDD/IVDD.

Release Date : 17 January 2018 | Country : European Union | Language : English

These FAQ, compiled by the EU Competent Authorities for Medical Devices (CAMD), deal with transitional provisions for the IVDR.

Release Date : 30 November 2017 | Country : European Union | Language : English

This is a list of the Team-NB (The European Association Medical Devices - Notified Bodies) members’ intention to submit their application to be designated against MDR and/or IVDR.

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