Regulation of the market of the medical equipment in Europe

2016: Introduction of new rules

At the end of May, 2016 the European regulators and legislators agreed about settlement of the market of the medical equipment. The reached agreement is directed to elimination of the normative spaces interfering development of technologies.

On May 25, 2016 the European Parliament and the European Council announced the agreement which assumes introduction of new rules for producers and suppliers of medical devices and the equipment for laboratory diagnostics (in vitro).

Europe regulates the market of the medical equipment

The version of the relevant bill considered in the first reading will be published in the middle of June, 2016, and is going to adopt new regulations for the European market of medical devices in the fall of 2016. After that the transient period will begin.

Equipment manufacturers for health care on which there is a marking of CE will have to fully to begin to conform to the new rules till fall of 2019. Producers of devices for diagnostics which is carried out in vitro will need to fulfill the similar requirement till fall of 2021.

Marking of CE (abbreviation fr.  Conformité Européenne  is the European compliance)  represents the special sign applied on a product certifying that the product conforms to the main requirements of EU directives and the harmonized standards of the European Union. Marking of CE indicates that the product is harmless to people and the environment.

As for new provisions which are going to enter the European authorities, they are directed to gain of rules of sales of medical devices in the market and also control of it. The initiative states specific duties for producers and equipment suppliers and also sets requirements for conducting examination of the equipment which work is connected with the increased risk for the person.^[1]

Шаблон:Subject Medicine

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