The MDR replaces the Medical Device Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC), the IVDR replaces the IVD Directive 98/79/EC.
In contrast to Directives, Regulations are directly applicable and do not need to be transposed into national law, lowering the risks of discrepancies in interpretation across the EU.
The new Regulations are designed to improve the quality and safety of medical devices on the EU market. In particular, they will reinforce the criteria for the designation of notified bodies and processes for their oversight; introduce stricter pre-market control of high-risk devices; and strengthen both clinical and post-market surveillance requirements.
The new regulations are more than a simple update to existing legislation, they require that every applicable device undergoes a brand-new conformity assessment. Devices that are already available on the market must undergo the same compliance process as new devices in order to comply with the new legislation. This represents a lot of time, resource and money for manufacturers, that will be turning to expert test houses and notified bodies for certification.
Manufacturers of current CE Marked medical devices will have until 26 May 2020 to comply. For devices already certified by a notified body under the Medical and Active Implantable Device Directives (MDD and AIMDD), this transition period can be extended until 26 May 2024. However, special requirements must be met to grant the extension.
Additional time is not foreseen for low risk devices such as class I and Annex XVI devices. These will need to comply with the MDR by May 2020 at the latest, otherwise they cannot be placed on the market and won’t be available for patients.
One of the main features of the Regulations is a completely new system of unique device identifiers, improving the identification and traceability of medical devices along the supply chain.
The new Regulations will also increase transparency. Summaries of safety and clinical performance for class III and implantable medical devices will be publicly available via the European Database on Medical Devices (EUDAMED). The database will include information on devices, economic operators, clinical research and post-market surveillance. EUDAMED will help regulatory authorities coordinate and exchange information and will be used to report and track incidents.
These major changes mean that it is vital that notified bodies are designated as early as possible, in order to have sufficient numbers available to assess devices before they are placed on the market. The designation process includes joint assessments which must be done by the joint assessment team, the designating Competent Authority of the Member State (where the notified body has its headquarters) and at least two further supervising Competent Authorities of other Member States. This joint assessment process is likely to allow a limited number of designation processes per annum.
Under the new IVDR, the number of IVD products that will now fall under notified body control has increased by approximately four times. As there are stricter requirements for the control of manufacturers by notified bodies, this has increased the assessment workload for both the IVD and MD sector.
With currently over 55 notified bodies in Europe, this could create a gap in certification services for the medical device market. It also makes it unlikely that all impacted manufacturers will have a notified body audit and certification on time for the new regulation.
Dr Bassil Akra, vice president global focus teams and member of the medical health service board at TÜV SÜD, says: “Some notified bodies are introducing the rumours that even the notified body number will change with the new MDR. This is incorrect, it is just applicable for notified bodies which are changing their location. Check the EU Commission Website to get more details.”
The complex development process for medical devices combined with the MDR changes are likely to make the transition period a complicated, time consuming and stressful process for many device manufacturers. On top of this, the lengthy process in the notified body designation process means that MDR certification by notified bodies cannot yet be offered.
Some firms that have not yet finalised a comprehensive strategy to ensure compliance after the shift to MDR/IVDR may experience delays to new products or product changes being placed on the market.
Since a large number of devices are expected to require notified body review and approval, manufacturers of currently approved devices and quality management systems are advised to evaluate potential compliance issues and to develop a plan and introduce measures to address them promptly.
“Read the regulation(s) first, don’t wait for somebody else to explain them to you,” Dr Akra urges: “You will identify the impact by reading and doing your specific impact assessment on your product portfolio. Start today and be ready for the future, prepare yourself as soon as possible.”
Keeping up with Medical Device Regulation
New conditions will need to be addressed for most legacy devices (CE marked under the previous regulations).
Any existing products must be recertified to abide by the new regulations.
Most companies will henceforth be required to update clinical evaluation,collect clinical data, technical documentation, and labelling.
Unique Device Identification will be enforced to help track devices throughout the economic operator supply chain and will be added to all labels.
Broadened definitions of regulated devices
The new regulation is three times longer than its predecessor and has significant changes in the wording used. Companies will need to rationalise their portfolios and conduct global impact assessments to implement the changes necessary to remain compliant.
Medical purpose devices and active implantable medical devices are now included in one regulation.
The EU medical device regulation changes will also see the definition of medical device broadened to include non-medical and aesthetic devices which were not previously regulated, including for example contact lenses, liposuction equipment and epilation lasers.
Heightened safety measures and risk management
Manufacturers will need to provide more in-depth clinical data which proves safety, performance and any clinical benefit claim and have tighter equivalency standards.
Manufacturers will have to report all incidents, injuries and deaths into an EU portal that will contain relevant data, so patients have access to safety-related information. The deadline for reporting incidents that did not result in death or serious deterioration in health has been changed from 30 to 15 days.
Companies which are transitioning will need to revisit core processes including but not limited to quality assurance, risk management, and post-market expectations.
Many medical devices will be reclassified as higher risk and new classification for reusable surgical devices and class IIb implantable devices have been introduced.
In vitro diagnostics are now classified into four risk classes. A notified body involvement will beneeded for about 70% of the devices rather than the current 30%.