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28. 02.2019

First guidance on new rules for certain medical devices

EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices .

The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain types of medical devices and in-vitro diagnostics. The Agency is working closely with the EU regulatory network and with stakeholders from the pharmaceutical and medical device industries, including notified bodies, to ensure a smooth transition to the new regulatory framework.

“With the ever-increasing pace of innovation and the blurring of traditional boundaries between medicines and devices, it is inevitable for the Agency to assume new responsibilities in regulating complex medicines with a medical device component. The big challenge we face is to ensure we have the appropriate expertise and resources to adequately carry out these new tasks,” said Guido Rasi, Executive Director of the Agency.

This first questions and answers (Q&A) document , developed jointly by EMA and the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) in close collaboration with the European Commission, focuses on the implementation of Article 117 of the medical devices regulation, which stipulates that marketing authorisation applications for medicines with an integral medical device must include the results of the device’s assessment of conformity by a notified body. Approximately one in four centrally authorised medicines includes a medical device component, and the majority of these involve an integral device. This includes for example pre-filled syringes and pens, patches for transdermal drug delivery and pre-filled inhalers.

EMA will publish further updates to the Q&A document addressing other requirements for various categories of devices, including those made of substances that are systemically absorbed, products which are not clearly defined as medicinal products, known as ‘borderline products’, and in vitro diagnostic tests used to determine patients’ eligibility for a specific medical treatment.

Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) replace the three existing medical device Directives (93/42/EEC, 98/79/EC and 90/385/EEC) and came into force on 25 May 2017. The two new regulations will come into full application in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices, following a transition period to allow manufacturers, notified bodies and authorities to comply with the changes.

Source: EMA