March 31, 2020
Amongst the many upheavals caused by the coronavirus pandemic, a significant one for the life sciences sector is the proposed delay until May 2021 of the full application of the new EU Medical Device Regulation (EU) 2017/745 (the MDR), which had previously been due to come into force in May 2020.
The MDR replaces existing Council Directive 93/42/EEC on Medical Devices (MDD) which, as the name suggests, is now over 25 years old. The MDD governs the classification, safety and testing requirements for medical devices in the EU, including (where applicable) the CE marking requirements for medical devices. The definition of ‘medical devices’ covered by the MDD is very broad, encompassing any instruments, appliances, software (including e.g. mobile phone apps) and pretty much anything else designed for diagnosing, preventing, monitoring or treating human disease, injury or handicap (including where those devices deliver medicines - such as syringes). It also covers contraceptive devices, and those designed to investigate, replace or modify human physiology. There are additional specific EU directives covering active implantable medical devices like pacemakers, and for in vitro diagnostic devices.
Due to the number of scandals around medical devices over the last decade or so – in particular those concerning breast implants, vaginal mesh products and pacemakers – along with increasing concerns around the safety monitoring and reporting of medical devices generally, there was a great push to modernise the EU medical device regime. This resulted in the new MDR entering into force in 2017, containing an enhanced classification system, stricter controls on high risk devices, greater post-market surveillance and inter-state coordination, along with many other improvements. The new MDR also now encompasses active implantable medical devices. Similar updated regulations have been made for in vitro diagnostic devices.
However, to allow manufacturers to transition to the new regime, the MDR’s provisions were scheduled to come into force after 3 years, in May 2020. With the considerable challenges faced by industry in general due to the coronavirus, along with the specific focus of medical device manufacturers on producing as many relevant products as they can to aid the fight against COVID-19, the EU Commission announced its intention to seek a delay of the full application of the MDR until 2021. The Commission’s proposal will be submitted to the EU Parliament and Council in early April. The full application of the new in vitro diagnostic device regulation is not due until 2022, and so is currently unaffected.
If you have any questions on the application of the MDR, and whether or not it applies to your products or software, please contact us.
Technology is evolving, and so are your lawyers. Find out more about our technology offering here.