Simply put, failing to comply with the new medical device (MDR) and in-vitro diagnostic (IVDR) regulations is not an option for companies that wish to continue developing these devices once the transitional period comes to an end in 2021. The regulations are absolutely critical to the future success of medical devices companies. Here’s why:
Perhaps the most obvious result of not complying with the new regulations is that your products will no longer make the cut for market authorisation. Both old and new devices will fail to meet crucial requirements outlined by the new legislation. These new requirements are far-reaching, affecting every single stage of the medical device life cycle including clinical investigation, manufacturing and quality assurance. As patient safety is a central concern of the new regulations, avoiding compliance will result in your products being deemed unsafe for use and they will not be granted market access.
Furthermore, due to the new classification system, many of your existing devices may need to be re-classified and the new system will need to be applied to future products.
The MDR and IVDR regulations will require a thorough review of almost all of the processes you have in place. Primarily, this will be for manufacturing but the processes for clinical evaluation, risk management, quality management, supply chain and post-market surveillance will also need reviewing, among others. Failing to do this will result in products that do not meet satisfactory criteria, and regulatory agencies will be forced to take action.
As the role of notified bodies (NBs) is changing significantly, the current processes used to work with these regulatory bodies will need to be adapted, or in some instances, completely changed. NBs will now be acting more like regulatory enforcers and some medical device companies will have to change their NB partner if it has been re-designated to review different types/classes of devices. Therefore, new processes must be implemented to support this changing relationship.
Another direct result of not complying with the new legislation is that you will be entirely unprepared and unequipped to deal with the increased workload. Hiring additional personnel is unavoidable because of the need for more clinical data and reporting, tighter quality control, and extra post-market surveillance and clinical follow-up. Following the announcement of these regulations, there is bound to be a scramble for resources as medical devices compete against each other to hire the personnel that they need to fulfil the extra requirements.
You will also be burdened with significantly more administrative work and you will not have the time or resources to manage the changes. Your ability to manufacture devices will be severely impaired.
All the above boils down to this critical point: if your processes and products do not comply with the new regulations by the end of the transition period, you will fail future audits and inspections carried out by regulatory bodies, such as NBs and the country specific competent authority for medical devices (i.e. the UK’s MHRA).
This will lead to issues of notice and warning letters demanding that you make immediate changes and resolve all outstanding issues so that you can continue developing, manufacturing and selling medical devices and IVDs. If there are ongoing, unresolved issues, audits and inspections will be escalated quickly to include more in-depth checks that may impact your operational capabilities, and in the worst-case scenario your company will be shut down.
Products in continuous violation of patient safety laws and medical device regulations will be considered dangerous for patients, and the company will incur financial and/or legal consequences. Serious offences can lead to unlimited fines or even imprisonment for those responsible, for example, the quality assurance Responsible Person(s).
It’s important to note that liability will be increased for several parties as all entities (manufacturing, distribution and importation) are now responsible for compliance. This can put your company in serious trouble and affect your ability to continue trading medical devices. If you continue spending money producing devices that are not fit to be sold according to the new standards, this will have a significant impact on your company’s revenue.
The important message here is that there is no way to avoid compliance with the new MDR and IVDR if you wish to continue manufacturing, distributing and/or importing medical devices or in-vitro diagnostics. With such a limited time frame, it is advisable to begin performing a gap analysis immediately and recruit the additional personnel needed to start the transitional process.
ProClinical is a specialist life sciences recruitment agency with many years’ experience recruiting various life science professionals for medical device companies. We are well equipped to source both individuals and/or entire teams to help medical device companies to navigate the MDR and IVDR as smoothly and efficiently as possible. Find out more here.