Regulation of the European Commission No. 745/2017 (MDR) significantly changed the requirements set out in the current Directives 93/42 / EEC and 90/985 / EEC was prepared for many years. After long expectations, in 2012 the first proposal for a Regulation was presented, which is much more restrictive than the applicable law. Therefore, many significant comments and proposals for the Regulation were made, so it lasted up to 5 years to publish the final version. Therefore it is not surprising, that companies and organizations in the medical industry have been worried by the fact about short implementation period of the new law.
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The EU Medical Device Regulations 745/2017 (MDR) and 746/2017 (IVDR) will soon progressively replace the current directives, which have functioned in the EU legislation unchanged since the 1990s. Thus, the European Commission and other legal organisations across the Member States need to make sure medical companies have a qualified regulatory expert within their organisation to ensure the company’s compliance with the EU requirements.
COVID-19 disease, caused by coronavirus, is primarily transmitted by droplet infection through contact with infected persons. When an infected person coughs, sneezes or talks, small airborne particles are transferred to another person. There is currently a very high demand for protective equipment designed to provide protection against airborne particles, including protective masks, medical gloves, overalls and face shields. These items of personal protective equipment, which are used primarily to protect the health of medical professionals and infected persons in health care facilities, are classified as medical devices. The most important aspects to consider when placing new personal protection medical devices on the market are presented below.
The purpose of this article is to address the interpretation of the provisions in Article 16 of EU Regulation 2017/745. Recently, misinterpretations of the regulations contained in that Article have been voiced at medical device conferences. Our analysis and its outcome are consistent with the interpretation advocated by 27 notified bodies in the area of medical devices that take part in regular meetings of the Notified Body Group. It is not by chance the fact that those meetings are also attended by representatives of the European Commission.