Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021.
The Medical Device Regulation (MDR), which was adopted in April 2017, changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for EMA and for national competent authorities in the assessment of certain categories of products. The Regulation entered into force in May 2017 and had a staggered transitional period.
The MDR introduces new or revised responsibilities for EMA for:
- medicines with an integral device, such as pre-filled syringes and pens, and pre-filled inhalers;
- medical devices containing an ancillary medicinal substance to support the proper functioning of the device. Examples include drug-eluting stents, bone cement containing an antibiotic, catheters coated with heparin or an antibiotic agent and condoms coated with spermicides;
- medical devices made from substances that are absorbed by the human body to achieve their intended purpose;
- borderline products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements.
For further details, see Medical devices.
EMA has worked closely with the European Commission, the national competent authorities, notified bodies and with stakeholders from the pharmaceutical and medical device industries, to ensure a smooth transition to the new regulatory framework.
To support the implementation of the MDR, updated guidance on quality requirements for medical devices in human medicines that include a medical device, as well as an updated Q&A, are currently under preparation and will be published shortly.
The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC). The Regulation on in vitro diagnostic medical devices, which also came into force in May 2017, will replace Directive 98/79/EC when it comes into application on 26 May 2022.