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Manufacturers MD

Manufacturers MD

As under the current regulatory regime, manufacturers of 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 MDR has the same basic requirements as the 2 previous Directives. It is generally more stringent than the Directives, 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 MDR by May 2020. 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 chosen 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.

Below you will find information to help you to comply with the Regulation such as factsheet and step-by-step guide for MD manufacturers, it includes information and links from third parties such as the Competent Authorities for Medical Devices (CAMD). Draw up an action plan and start preparing to be ready on time for the MDR.

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 : 5 May 2018 | Country : European Union | Language : English

This page provides an overview of the transition period from the Medical Devices Directives to the Medical Devices Regulation and explains the impact for medical devices being placed on the market during the transition period.

Release Date : 28 April 2018 | Country : European Union | Language : English

This presentation provides an overview of the changes and impact of the Medical Device Regulation, from the point of view of a Notified Body.

Release Date : 23 March 2018 | Country : European Union | Language : English

This presentation deals with UDI tracing and reporting requirements in the MDR and IVDR.

Release Date : 9 November 2017 | Country : European Union | Language : English

This MedTech Europe Position Paper on Article 50 Negotiations between the European Union and the United Kingdom discusses what this process will mean with regards to the new Regulations.

Release Date : 6 April 2018 | Country : International | Language : English

This presentation, by a member of the Irish Health Products Regulatory Authority, deals with registries within the context of the Medical Device Regulation.

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