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Medical devices are an essential part of the delivery of high-quality healthcare to patients all across Europe. In many countries, their procurement and management in the hospital setting falls often under the authority of hospital pharmacists. To further improve the safety of medical devices for European patients, a new regulatory regime was adopted in spring 2017 encompassing both the Medical Device Regulation (MDR) (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC) and the Invitro Medical Device Regulation(Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU). With the MDR becoming fully applicable from May 2021 onwards, the European Association of Hospital Pharmacists (EAHP) would like to use this occasion to reiterate some of the considerations raised by hospital pharmacist in EAHP’s Statement on the Medical Device Regulation adopted in 2014 and EAHP’s Opinion on this topic released in 2019.
EAHP welcomes the reinforcement of the supervision of notified bodies, the strengthened clinical evaluation and the improved surveillance and vigilance mechanisms introduced by the MDR. In relation to the latter, EAHP would like to express its support for the requirements mandating manufacturers to report serious incidents and corrective actions they have taken to reduce the risk of recurrence. However, given that systems for pharmacovigilance reporting by health professionals in respect of medicines are well established across Europe, EAHP would also like to see further empowerment of healthcare professional and patient reporting, in particular, reporting from hospital pharmacists specifically trained for this task. Ensuring reporting processes for devices and medicines are of a similar …
Competing interests None declared.
Provenance and peer review Commissioned; internally peer reviewed.