Internal Market, Industry, Entrepreneurship and SMEs

Healthcare professionals and health institutions

Healthcare professionals and health institutions

As a healthcare professional you need to be aware that the Regulations are more stringent than the Directives: in general they retain the existing requirements and add new ones. The Regulations emphasise a life-cycle approach to safety, backed up by clinical data.

You should also be aware that, during the transition from Directives to Regulations and for a few years afterwards (until 2025), some products certified under the Directives and products certified under the new Regulations will coexist on the market.

The Regulations introduce new rules for in-house devices, custom-made devices, clinical investigations, reprocessing of single-use devices, and distance sales. They also require implant cards for patients. They strengthen the rules for the designation of notified bodies – the independent evaluators of manufacturers and their devices.

In addition, the Regulations introduce a system of unique device identifiers (UDIs) and a new European database for medical devices and in vitro diagnostic medical devices (EUDAMED). This will improve openness by making data available and increasing both the quantity and quality of data, and by enhancing the identification and traceability of medical devices.

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

This newsletter from the European Hospital and Healthcare Federation contains an article on a survey related to the introduction of the MDR and IVDR conducted among 169 professionals working in medical device and IVD firms.

Release Date : 30 April 2018 | Country : European Union | Language : English

This newsletter from the European Hospital and Healthcare Federation contains an article on a communications campaign by the Commission related to the introduction of the MDR and IVDR.

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 : 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.

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