The Medical Devices Regulation (EU) 2017/745 (MDR) becomes applicable in the European Union today, 26 May 2021.
The MDR replaces the existing Directives for medical devices (93/42/EEC and 90/385/EEC). It entered into force in May 2017 and had a staggered transitional period. It changes the European legal framework for medical devices and introduces new principal and supportive responsibilities for the EMA and for national competent authorities in the assessment of certain categories of products.
The MDR introduces new or revised responsibilities for EMA for:
- medicines with an integral device, such as pre-filled syringes, pens, and pre-filled inhalers
- medical devices containing an ancillary medicinal substance to support the proper functioning of the device e.g. 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.
To support the implementation of the MDR, the following will be published imminently:
- updated guidance on quality requirements for medical devices in human medicines that include a medical device
- an updated Q&A currently under preparation.
Source: EMA website