The Medical Devices Regulation
The regulatory regime for medical devices, technologies and diagnostics is complex and undergoing its most significant change for thirty years.
The EU Medical Devices Regulation (MDR) replaces the current Medical Devices Directive. The MDR entered into force on 25 May 2017, marking the start of a three-year transitional period for manufacturers selling medical devices in Europe.
Crucially, the MDR does not include any provisions for “grandfathering” existing approved devices. Every device will need a new CE Mark.
Apart from a relatively small number of products that will be “up-classified”, the most significant changes in the MDR are:
- increased requirement for high-calibre clinical data (both pre-market and post-market);
- a discontinuation of reliance on “equivalence” of one device with another approved device;
- increased requirements for post-market surveillance (such as an annual update of Clinical Evaluation Reports
- a new “scrutiny” process for new “high risk devices”
- restrictions on the advertising of medical devices (an entirely new element to the regulatory framework); and
- regulation of all MAIDs: Manufacturers, Authorised Representatives, Importers and Distributors.
These requirements impact every aspect of the development, manufacturing, promotion, sale, distribution and monitoring of medical devices. As a result, preparation for the MDR is a multi-functional exercise, impacting commercial and marketing teams, medical affairs, HR and even the company’s IT systems. This is not limited to an assessment of the devices themselves, which should have started some months ago.
We work with clients to assess the new requirements and determine the impact of the MDR on current and pending devices. This dynamic landscape is challenging for all stakeholders. Inevitably regulators, notified bodies and payers struggle to understand and implement the new requirements. We help clients with their interactions with regulators, notified bodies and payers.
While there will be a significant administrative burden for most devices, there will be strategic opportunities.
For some clients this will take the form of M&A and licensing opportunities. Others are using MDR as an opportunity to review their product portfolios and pricing strategies. A small number of clients will fundamentally change the way they market their devices, with some innovators considering entire marketing and reimbursement campaigns focusing on MDR compliance.