Rynek wewnętrzny, przemysł, przedsiębiorczość i MŚP

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 : 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 : 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 : 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 is a Summary Report from a European Society of Cardiology (ESC) meeting that discussed the safety and performance of medical devices, how the new European regulatory landscape impacts that, and what opportunities lie ahead for the involvement of eXperts in the regulatory process.

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.

Subscribe to RSS - Manufacturers MD