In April 2017 the European Parliament and the Council adopted new Regulations on Medical Devices (MDR) and Invitro Diagnostic Medical Devices (IVDR), representing the biggest overhaul of medical devices regulation in the European Union since the early nineties.
The medtech sector in Europe is in a state of flux. The impact of the new MDR, which becomes applicable on 26 May, will be transformative, particularly as such impact will be felt at a time when companies are also coping with changes from the GDPR and uncertainties around Brexit and the potential break down of the EU-Swiss relationship and mutual recognition.
Pre-market stage and smaller, less-established companies could particularly feel the strain as such companies have fewer resources to handle the changes; large providers may also face financial headwinds owing to the number of products in their portfolio. Developers of high risk medical devices and implantables are used to a higher regulatory burden under the current framework so the impact may be less.
With less than three months to go until the rules of the MDR become applicable, what is the state of play?
One of the key changes under the MDR is that all products, including those placed on the market prior to the regulation, must be CE marked. This requires products to be subjected to conformity assessments to be conducted by notified bodies that also need to be re-accredited under the MDR. The requirements for notified bodies under the new regulation are more stringent than before and many notified bodies have not sought re-accreditation. This has resulted in a lack of capacity at notified body level, with some, particularly smaller, companies struggling to find a provider with capacity.
Many medical device products currently on the market do not meet the evidence requirements under the new MDR, meaning manufacturers will need to collect further evidence through clinical studies. The MDR provides a grace period during which many products currently placed on the market may continue to be marketed based on their Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) CE certification until its expiry date or until 27 May 2024. However, in the case of significant changes to the design and intended purposes of products, re-certification under the MDR will be required. In practice, many companies have sought to re-certify their products under MDD or AIMD before the 26 May 2020 deadline to allow more time for further evidence collection. This has resulted in further strain on notified body capacity and a real possibility of products becoming unavailable if companies cannot re-certify in time.
Other obligations under the MDR, which must be applied by May, include the requirement for manufacturers to align their quality systems and clinical evaluation procedures to conform with the new regulation. Eudamed, the database that will form the backbone of the regulatory system under the MDR, will not be operational until 26 May 2022 and so manufacturers’ obligation to enter data into the database is postponed. Other obligations under the regulation will have gradual implementation dates.
The Regulation is aimed both at modernising the rules in place as well as strengthening the system following criticism that the existing regulatory regime was not robust enough. The new rules are certainly more robust, but it remains to be seen what effect this will have on the EU medical device market.
