With the EU Medical Device Regulation (MDR) being phased in and now applicable, we look at the challenge of finding regulatory experts to help companies stick to the new requirements, and the basic steps to get on the road to compliance.
Medical devices, which range from pacemakers and cochlear implants to implantable nerve stimulators, software and transmitters, are becoming increasingly important in the treatment of diseases and disorders, as well as maintaining health.
To demonstrate the safety of these medical devices, manufacturers and their devices previously had to fulfil the requirements of the European Union's Medical Device Directive (MDD; Directive 76/764/EEC) or the Active Implantable Medical Devices Directive (AIMDD; Directive 90/385/EEC). However, over the years, medical device technology has advanced beyond the remit of these directives. There have also been a number of medical device scandals in the EU, and governments have interpreted the directives and their national implementing laws in different ways.
To enable a level playing field across the EU and reassure both healthcare professionals and patients about product safety, the EU created the MDR (Regulation (EU) 2017/745). Unlike the MDD and AIMDD, the MDR is directly applicable and not implemented by national laws. But as with any new laws, it can be tricky for companies to get their heads around the changes and make sure they comply.
The MDR milestones
The MDR came into force on 25 May 2017 and fully replaced the MDD and AIMDD on 26 May 2021. It provided most companies with a three-year transition time to continue marketing medical devices previously approved and marketed in accordance with the MDD or AIMDD. The original deadline was extended by a year because of the impact of Covid-19. Between May 2021 and May 2024, certificates issued by notified bodies, under either the AIMDD and MDD, remain valid on certain conditions. After 26 May 2024, all devices to be placed on the market must conform to the MDR.
According to Greenlight Guru's 2021 survey, only 18% of medical device companies were fully ready for the May 2021 MDR deadline, just over half (53%) expected to be ready, and around a third (30%) were unlikely to be ready. Most manufacturers would be able to rely on the transitional period for existing medical devices but would not be able to launch new medical device products in the EU unless they complied with the MDR.
The challenges of compliance
The scope of the MDR is broader than the MDD. The key differences between the MDR and MDD are:
- The MDR is longer and more detailed, and has a greater focus on safety than the MDD
- Devices will need more in-depth clinical data to support safety and performance; there are also greater requirements for quality assurance, risk management and post-market surveillance
- The MDR has led to many devices being up-classified, especially software, and being subject to more stringent requirements. The MDR also introduced rules for devices with no medical purpose, such as non-prescription coloured lenses
- The MDR will require medical devices to undergo a conformity assessment procedure in accordance with the MDR, including for medical devices that have been on the market for many years
- All medical devices will need to have a Unique Device Identifier (UDI)
- Companies need to report incidents, injuries and deaths in an EU portal (EUDAMED);
- Economic operators, such as distributors and importers, now have defined roles and obligations
The MDR requires medical device manufacturers and authorised representatives to have a regulatory expert (Person Responsible for Regulatory Compliance or PRRC), who ensures organisations meet the requirements of the MDR. However, finding people willing to take on this role has been tough, according to Alexander Wenzel, an associate at Cooley, who helps medical device manufacturers navigate these regulatory requirements. This is because of uncertainty regarding the role and the level of liability PRRCs are taking on.
"There are a lot of new obligations under the MDR. Some of these have always existed but haven't been enforced, but they’re now in law," says Wenzel.
These changes will increase costs for medical device companies. The time taken to register products is likely to be longer, especially in the early days of the MDR, as there will be more discussion over the requirements.
Resourcing the MDR
In the Greenlight Guru survey, 59% of respondents said resourcing (time and budget) was a significant barrier to complying with the EU MDR, and 46% cited planning (confusion over what is required and steps to complete). While some companies have staff with the right experience and expertise in-house, others are having to seek external support, and this has proved to be a significant bottleneck for the process.
"Companies are struggling to find expertise – it's not something that can be learned overnight," says Charmaine Scott-Hibbert, Managing Director at the regulatory consultancy Adaptive Device Solutions. "There weren't enough people in the area previously, and the MDR has brought it to the surface."
The problem has been exacerbated by the perfect storm of Brexit, the pandemic and people reaching retirement age. To meet their needs, companies must find support, both in the short and long term.
In the short term, external experts can provide this assistance. Scott-Hibbert's advice is not to struggle on alone, but to use contractors to get through.
"There is a lot more data required under the MDR – don't underestimate the money and time needed," notes Scott-Hibbert.
Some companies use internal staff but rely on external specialists for specific roles. Adelina Chiaravalloti, Director of Regulatory Affairs and Clinical Evaluation at CORCYM, a cardiac medical devices company, says: "We brought in several trainers from outside, including from notified bodies, for all company stakeholders involved in the MDR projects."
Consultants can also train on specific topic that are new or expanded in the MDR, for example the requirements for clinical evidence or post-market surveillance.
CORCYM brought in a technical writer on the documentation, including the Summary of Safety and Performance (SSP) and Periodic Safety Update Report (PSUR), to support internal staff, who were overloaded.
"It was challenging to find the expertise we needed in a technical writer," explains Chiaravalloti.
Time and money
Resolving the issue long term will require time and investment. Working in regulatory affairs isn't necessarily something people hear about as a career choice, according to Scott-Hibbert. One solution for the future is to educate people about the opportunities and provide education and hands-on training for people entering the workplace. Another is to upskill people in related regulated areas within the company, through mentorship, on-the-job training, shadowing and job swaps. As well as solving issues internally, this training will provide expert people who can work as consultants in the future.
"Long term, companies need to train a lot of new people," adds Wenzel.
Individuals currently in a regulatory affairs team will require additional support until the pressure on them eases. The MDR affects the whole company, not just regulatory affairs, so companies need to train everyone on the requirements of the new standards.
Chiaravalloti’s top takeaways to meet the challenges of the MDR are to study the regulations and ask questions, read the guidelines, build knowledge within your company where possible, take up offers of training from the notified bodies (as this ensures a company knows what the notified body expects to receive), and bring in consultants where necessary. It's important to have internal knowledge in the long term, so the training is crucial, she stresses.
Don’t be afraid to ask for help – get support from people who know your device type and have real experience of submitting to the MDR.
If you need regulatory consultants to aid your organisation’s transition to the MDR