Blog series: Maintaining Regulatory Momentum in the Covid-19 era:

Preparation for the new regulations 

The global disruption caused by the pandemic meant regulatory plans for 2020 needed to be delayed to give the life sciences industry and authorities breathing room. However, it is important to keep up to date with imminent regulatory changes that will impact the industry. In my last blog in this series (Getting Ready for the Clinical Trial Regulation) I discussed some key things to look out for now that the Clinical Trials Regulation implementation has been confirmed for December 2021.

“The implications of not being ready are severe: loss of CE mark certification”

May 2021 – Are you ready? 

This year, key regulations such as the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) are back on the agenda. As of May 2021, medical devices companies will need to ensure they are ready to meet the regulation. The implications of not being ready are severe: loss of CE mark certification.

The MDR and IVDR bring medical devices more closely in line with medicinal product regulations in terms of clinical efficacy, vigilance and product oversight – whether that’s an implant, a surgical device that is sterilised and reused or a complex piece of machinery such as an MRI. For companies, that means having good quality management to ensure requirements are met.

Finding the correct Notified Body 

One of the biggest challenges will be finding a notified body, since many have withdrawn their services in the re-qualification process, and those qualified and able to operate under MDR and IVDR have limited capacity. Potentially, companies that have not yet identified a notified body or started conversations with them could struggle to get their CE certification updated and approved in time.

Finding relevant regulatory expertise 

Another challenge will be finding enough people with regulatory experience in medical devices. Given the likely shortage, companies will need to start training their staff on these new regulations, rather than relying on recruiting the right people.

MDR Impact Assessment and Actions 

I would hope that all companies have started their impact assessments by now since these could be very time-consuming, involving several years-worth of toxicology reports and clinical investigations as well as looking into the real-world data.

Inevitably, there will be some products that are not worth the work involved for the manufacturer and these will likely be lost to the market. There are pros and cons to this. If the product can’t meet the standards required, it’s likely they shouldn’t be on the market; on the other hand, if products are lost to the market, how will that affect supply and demand and the broader needs of the healthcare system?

The pandemic gave companies a breather, but there is no time left to lose to prepare for the MDR. Companies would be wise to ensure they have the support they need to meet the tougher new requirements or seek help from experienced regulatory consultants.

To help you stay abreast of such regulatory changes our Regulatory On-Call service provides personalised responses to your ad hoc regulatory enquiries by way of a monthly retainer, get in touch for more information. Also look out for the other blogs in this series relating to General Data Protection Regulations and MHRA guidance on Orphan Drugs; work programmes that have not gone away but may have drifted from focus in the current environment.

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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
    MDR/IVDR compliance
  • 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
    evaluation activities

Develop sound regulatory strategies and initiate dialogue without delay…
You run the risk of losing access to the EU market…

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