As reported by the European Commission, medical devices and in vitro diagnostic medical devices, ranging from simple contact lenses and sticking plasters to sophisticated pacemakers and hip replacements, are important to our health and quality of life. People rely on these devices every day and expect them to be safe and to incorporate the latest progress in science and innovation.

The Regulation on Medical Devices (MDR) and the Regulation on In-Vitro Diagnostic Medical Devices (IVDR) will, within a transitional period, replace the current Medical Device Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and the In Vitro Diagnostic Medical Device Directive (98/79/EC). The transitional period for the new MDR is of three years while the transitional period for the IVDR is of five years.

In Malta, aside from the Medical Devices Regulations (S.L 427.44), we have two regulations being:

• The Invitro Diagnostic Medical Devices Regulations (S.L 427.16); and
• The Active Implantable Medical Devices Regulations (S.L 427.10).

These regulations transposed the said directives and will be replaced by the MDR and IVDR. The MDR and IVDR, being Regulations and not Directives, however, will not require actual transposition for direct effect in member states and will have the force of law throughout the entire EU when the transitional period is over.

The Regulations differ in several important ways from the existing regimes for medical devices, active implantable medical devices and in-vitro diagnostic medical devices, and the MDR and IVDR will introduce a series of important changes with a view to modernising the existing regimes.

1. Enhanced documentation and surveillance requirements

Manufacturers must provide clinical data concerning their medical devices (which can also include software), and they must adjust the present data in order to place or retain their medical devices on the EU market.

Together with other parties in the distribution chain, manufacturers will be obliged to verify each other’s regulatory compliance and revisit existing Quality Management Systems, Post-Market Surveillance and Vigilance Procedures. These obligations are particularly important, since notified bodies will be entitled and obliged to carry out unannounced inspections to verify continued compliance. The post-market surveillance system shall be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and determining, implementing and monitoring any preventive and corrective actions.

Medical device manufacturers must also continue to make an EU declaration of conformity for their devices, and most of the products must bear a ‘CE’ marking to certify their compliance.

2. Transparency

The MDR provides for stricter rules on transparency due to the creation of:

• An ‘implant card’ for patients containing information about implanted medical devices that will make information easily available and accessible to the patient.
• A comprehensive EU database on medical devices (EUDAMED) that will contain a living picture of the lifecycle of all products available on the EU market. A large part of the information will be made publicly available, including a newly introduced summary of safety and performance for all Class III and implantable devices. EUDAMED will provide access to information on the part of the public and healthcare professionals and streamline regulatory reporting.
• EUDAMED will also include the Unique Device Identification (UDI), which is a system for marking and identifying medical devices to enable better traceability and recall.

3. Classification rules

The classification rules in the existing Directives have been modified, and manufacturers will need to review the updated classification rules and update their technical documentation accordingly. Notably, manufacturers must assess whether their medical devices may be reclassified, such as software used for decision support or monitoring being classified in a higher risk class. For certain high risk devices, the new Regulations require the Notified Bodies to consult with an expert panel before placing the device on the market. Per this procedure, an expert panel could provide a scientific opinion to the notified body on its assessment of the manufacturer’s clinical file. While the notified body would not be bound by the opinion, it would have to provide a justification for not following it.

4. Security

The Regulations contain very important changes to the current system to enable the sector to produce safer and more innovative devices and help address future challenges. The new Regulations contain many provisions to increase security and regulatory certainty (harmonised rules on drug-device combination products, tissue engineering, nanoscience, personalised medicine, substance-based devices and genetic tests) and consider the latest developments in the sector (medical software, apps, cybersecurity).

5. Compensation Mechanisms

The Regulations require manufacturers to have measures in place to provide sufficient financial coverage in respect of their potential liability. Such financial coverage shall be proportionate to the risk class, type of device and the size of the enterprise. This should allow patients to be rapidly and effectively compensated, also in case of financial bankruptcy of the relevant company.

For more information or if you have any questions, please feel free to contact Dr Ian Gauci on igauci@gtgadvocates.com

Disclaimer: This article is not intended to impart advice and readers are asked to seek verification of statements made before acting on them.