Regulatory change within the world of medical devices is in full throttle with the adoption of the Medical Devices Regulation and the In Vitro Diagnostics Medical Devices Regulation, on 5 April 2017. The new regulations are not a radical overhaul on medical devices but do represent much needed modernisation of a working, but increasingly outdated, system.
At a glance, the Regulations:
- Reinforce the Notified Bodies designation criteria and reclassify certain medical devices. Far more devices are classified as medical devices under the Regulations where they were previously classified as general products, and would not have fallen within the scope of the existing regulatory regime.
- Ensure greater safety controls and quality assurances by way of a new pre-market scrutiny mechanism for high-risk medical devices. Panels of independent EU experts will have to be consulted prior to a medical device being placed on the market.
- Strengthen controls and the requirement for clinical evidence to be both readily available and regularly updated by manufacturers. In addition, a single coordinated assessment procedure will be in place for authorisations of multi-centre clinical investigations within Member States.
- Enhance transparency and customers' access to medical devices by introducing a new implant card for implanted medical devices. This will ensure a consistent message on the risks and benefits associated with implanted medical devices is made available to customers. An extensive and publically available European database (EUDAMED) will also replace the limited information which has previously been available.
- Increase vigilance, pre-market surveillance and post-market surveillance by imposing more onerous obligations on manufacturers to collect data about the performance of medical devices and improve Member States' co-ordination and communication mechanisms with regards to market surveillance more generally.
- Introduce a financial mechanism to ensure patients injured by defective medical devices are fairly and consistently compensated.
Clearly, there is an additional burden that the Regulations place on, and expect of, medical devices stakeholders (producers, manufacturers and importers), not to mention regulatory authorities. The Regulations have the ultimate goal of improving the safety, quality and reliability of medical devices marketed within Member States, as well as improving consumers' access to information on such medical devices. A natural consequence of this is the introduction of additional hoops and hurdles for stakeholders to overcome when both obtaining and maintaining CE marking approvals for medical devices, thereby increasing their financial outlay.
There is a three year transitional period to allow the industry time for implementation, but stakeholders need to start, if they haven’t already, reassessing the value of their existing and future medical devices portfolio. Although the Regulations modernise and streamline the medical device regulatory system, they also add a further layer of review and approval associated with getting CE marking approvals.
As well as preparing for implementation of the Regulations, medical device stakeholders are faced with uncertainty surrounding the impact of Brexit. The MHRA task force on Brexit is working hard behind the scenes but whether, to what degree, and for how long the UK will be bound by the Regulations remains to be seen. Whilst companies trading across Europe will, of course, need to comply with the Regulations, this uncertainty and the increased financial cost of getting a medical device to market will potentially make business decisions for stakeholders difficult, especially for smaller companies attempting to navigate this transitional period - with respect to both the Regulations and Brexit.
The Regulations promote greater consistency, certainty and clarity across all Member States by building on a system that has historically, at least within the UK, been flexible and generally worked efficiently and well.
As the impact of these developments is still being fully understood, all stakeholders should invest both time and money in future-proofing their medical devices portfolio.