Regulation (EU) 2017/745 on medical devices is applicable in the European Union as of 26 May 2021.
The Medical Device Regulation (MDR), 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.