Changes to EU Medical Device Legislation: What you need to know
Claudia Samà, Business Development Manager, Eurofins Medical Device Testing Italy, ClaudiaSama@eurofins.com
On April 5, 2017, the European Parliament approved the New Regulations for Medical Devices (MD) and in-vitro diagnostic Medical Devices (IVD), proposed by the European Commission back in 2012. The final adopted text, Regulation (EU) 2017-745, was published in the Official Journal in May 2017. (http://eur-lex.europa.eu/ legal-content/EN/TXT/?uri=CELEX:32017R0745)
The two new Regulations replace the three existing Directives on MD. In detail, the EU Directive MD (93/42/ EEC) and the EU Directive on active implantable MD (90/385/EEC) are replaced by the Regulation on Medical Devices (MDR). The Directive on IVD (98/79/ EC) is also substituted by an up-to-date Regulation on the same topic.
While Directives require national implementation in every European country, the Regulations are directly enforced, overcoming issues caused by divergences in the national interpretation of the existing Directives.
The new Regulations aim to enhance patient safety through the introduction of numerous changes and improvements, involving both manufacturers and competent Authorities.
The definition of medical device is extended to groups of products without a medical purpose but similar to medical devices for their risk and characteristics (e.g. coloured contact lenses, facial dermal fillers).
The demonstration of medical device performance with stronger clinical evidence is another significant topic, as well as transparency of information for consumers through the new European database of MD (EUDAMED).
Safety improvements involve also the post-market surveillance, which obliges manufacturers to monitor products placed on the market, providing annual reports on their safety and performance. The Notified Bodies will have a strong authority in this subject by unannounced audits and samples controls.
Eurofins experts are happy to support manufacturers facing this changing regulation, providing testing and offering regulatory expertise during the entire medical device life cycle.
For more information visit: www.eurofins.com/medical-device/