The European Union (EU) Medical Devices Regulation (MDR) has taken effect from 26 May 2021. The Regulation revises quality and safety standards and the range of regulated devices. It was first initiated in May 2017, with an initial three-year transition period applied. However, implementation was delayed by 12 months due to the COVID-19 pandemic.
According to the European Commission there are over 500,000 types of medical devices and in vitro diagnostic medical devices (IVDs) on the EU market. These have a “fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease” according to information on the Commission’s website. Separate regulations governing IVDs come into effect in May 2022.
According to the Commission, the new regulations create a “robust, transparent, and sustainable” regulatory framework, that will improve clinical safety and create fair market access conditions for manufacturers.
The new regulations maintain the current grouping of devices into four classes—Class I, IIa, IIb, and III—although certain devices are reclassified and have a wider scope.
The Regulation also clarifies the respective obligations of manufacturers, authorised representatives, importers and distributors, with manufacturers required to put systems in place for risk and quality management, to conduct clinical or performance evaluations, and to draw up technical documentation and keep this up to date. Further to this, the Regulation also requires manufacturers to implement post-market surveillance follow-up plans.