When the Medical Device Regulation (MDR) and In-Vitro Diagnostic Device Regulation (IVDR) transition was launched earlier this year, medical device manufacturers were faced with a steep mountain of regulatory, legal, process and resource challenges that would need to be climbed in order to introduce new and continue supplying existing devices for use in healthcare. In this article, Tamsyn Frost of IDEA Regulatory explores the lessons learned in the pharmaceutical sector to describe a pragmatic approach to attaining and maintaining CE Marks in compliance with MDR and IVDR.
Over a 3-year timetable, every medical device currently in use in Europe, and every new device launched there, will need to comply to new stringent legislation. This presents a significant challenge to device manufacturers world-wide as, without the necessary certification, devices of all types will bebanned from use in the important European health-care market by May 2020.
The move follows a number of high-profile patient safety incidents within the devices sector, which highlighted the need for legislators to adopt more stringent safety protocols similar to those already in use in the pharmaceuticals sector. The Medical Device Regulation (MDR) (EU2017/745) replaces the Medical Device Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMD), and provides a uniform legal framework for devices across Europe.
Every medical device currently in use in Europe, and every new device launched there, will need to comply to new stringent legislation.
The scope of what is included as a “device” has also been clarified within the new article. Under MDR, aesthetic and non-medical purpose devices that pose a similar risk profile, nanomaterials and software are also included. All devices are then organized into classifications, with risk assessment and monitoring requirements that become incrementally more stringent as risk of potential harm increases.
MDR covers pre-market scrutiny, classification, manufacture, identification and traceability, and for all
but the lowest classification (Class I) of products, will require Notified Body monitoring of in-use performance. This means device manufacturers will need to adopt a number of important functions in
development, manufacture and on-going marketing of products, as well as appointing a Responsible Person to whom all compliance issues must fall. For device manufacturers, these additional functions
and responsibilities, and the workload required to transition to them, are somewhat daunting. Indeed, finding the right people with the right experience, able to understand the regulatory and legal frameworks,
and implement the necessary new procedures is already a major challenge. At the 2017 TOPRA Annual Symposium held in London, this concern dominated proceedings, with the device regulation sessions I attended repeatedly returning to the question of how the industry (manufacturers, NB’s and regulators alike) will find the resources necessary to meet the deadlines. These are uncharted territories for the sector, and with the May 2020 deadline looming, the pressure is on.
Leveraging expertise from Pharma
Perhaps unsurprisingly, these additional functions and responsibilities for the devices sector bare a strong resemblance to the long-standing practices in use by the pharmaceutical sector in the EU. Regulation, clinical data collection and management, legal responsibilities, batch production traceability, risk assessment and pharmacovigilance are all well understood practices for drug development, manu-
facture and distribution.
For example, under the new MDR rules, device manufacturers will be required to demonstrate an acceptable risk:benefit ratio, and for Class III (high risk) products, clinical trials will be required to demonstrate safety and performance, all with adequate data protection (GDPR) and country-specific legal cover. Within the pharmaceutical sector, health economics and clinical trials are so
specialized that these functions are separate disciplines, and legal representative cover frequently outsourced to territory-specific specialists.
Interpretation and pragmatism
In my conversations with some NB’s the EMA, and MHRA, one thing is clear – they do want device manufacturers to succeed. As with all things legal, the language and the rules seem impenetrable and immovable. After many years working with the regulatory authorities in the pharmaceutical sector, such “legalese” might best be seen as a framework around which discussion and dialogue should be fostered towards pragmatic interpretation of the rules so that both manufacturers and governing bodies can be satisfied that the product is both effective and safe, and being appropriately monitored pre- and post market launch. Such dialogue nurtures confidence that a manufacturer is seeking to embrace what is required and will, in my experience, receive plenty of good advice. Conversely, without dialogue these same governing bodies are left with uncertainty about a company’s intentions, and are left with little choice but to apply the rules rigidly. I have been surprised by just how many device manufacturers have yet to start taking MDR seriously, especially those based outside Europe. There remains a good deal of confusion and uncertainty for authorities and manufacturers alike. And Brexit throws yet more dynamics into the mix with the EMA being moved out of London and relocated in Amsterdam, and the need for UK manufacturers to begin the FDA’s MDSAPi process in order to compete in the USA and new markets such as Brazil, Canada, South Korea and Japan. With all of this uncertainty, I am advising my clients to develop sound regulatory strategies and initiate dialogue without delay. If you don’t already have a strategy for transitioning to MDR and IVDR compliance, you run the risk of losing access to the EU market when the regulations come fully in to force on 26th May 2020 and 26th May 2022 respectively.
Key steps checklist
- Verify whether or not your product is
classified as a Medical Device ii
- Understand your device classification iii, iv
- Develop a Regulatory Strategy for
- Put in place resources and expertise to
execute your compliance strategy
- Check your Notified Body has the
appropriate certification for your class of
- Foster dialogue with Notified Body and
Competent Authority, as required
- Appoint an EU Authorized Representative
- Appoint adequate EU Legal
Representation cover for clinical
Develop sound regulatory strategies and initiate dialogue without delay…
You run the risk of losing access to the EU market…