Both of the new Regulations retain the existing principles and fundamental components of the current regulatory system but each element is strengthened and better defined.
These improvements are:
The new Regulations have also been developed in line with experience of implementing the EU Commission’s 2012 joint plan for immediate action on medical devices, which has resulted in a step-change improvement in the EU regulatory system for devices.
The HPRA believe that these improvements will allow for an effective, consistent and robust regulatory framework for medical devices across Europe and will afford the public appropriate levels of health protection and access to safe and effective medical devices. Each of the foundations of the system are all significantly strengthened:
1. Improved performance of notified bodies for medical devices
Both the MDR and IVDR significantly increase the definition and clarity in the requirements that a certification organisation must have to become a notified body for medical devices.
The Regulations also build on experience of the EU joint assessment scheme for designation of notified bodies which provides for an independent EU level assessment of candidate notified bodies.
The new Regulations also place very specific obligations on national authorities to continue to monitor the performance of notified bodies based in their territory on an ongoing basis. These elements make the requirements and standards for notified bodies more consistent and will help ensure that their ongoing oversight by authorities is effective. This will lead to further improvements in the consistency, transparency and performance of notified bodies across the EU.
2. Clearer requirements for clinical data on medical devices and its assessment
The MDR provides increased clarity on the requirements for clinical data for medical devices, in particular those of the highest risk and improves the mechanisms for the assessment of clinical data throughout the lifecycle of a medical device.
The requirements for clinical studies (investigations) of medical devices are significantly enhanced and include many specific provisions to ensure that people enrolled in clinical studies are appropriately protected.
Further and increased emphasis is put in place on the need to gather and evaluate clinical data to demonstrate the safety and performance of a medical device on an ongoing basis.
Increased clarity about how clinical data from predicate or equivalent devices can be used as part of clinical dossiers is also provided.
In addition, across the Regulations a significantly increased amount of clinical data on medical devices will be made available to the public and to healthcare professionals.
The MDR will drive improvements in both the quantity and quality of clinical data available for medical devices.
3. More specific product requirements
The MDR places greater emphasis and increases the possibilities to develop specific criteria and specifications for high risk medical devices.
This may be of particular relevance in defining clinical data criteria and specifications to ascertain the performance and safety of a medical device.
Clarifying the requirements for medical devices, in addition to existing technical standards, will afford better protection to public health and help ensure medical devices available are safe and effective.
Clarity in the requirements and expectations will also allow for a great deal more consistency and predictability in the assessment of medical devices which results in a fairer, more secure system for manufacturers and device innovators.
4. Improved pre-market assessment of high risk devices
The new Regulations provide for additional pre-market scrutiny of the highest risk medical devices by an independent expert panel operating on behalf of the European regulatory system.
The devices subjected to scrutiny can also be selected for review based on specific clinical concerns or emerging safety issues with similar devices.
The independent panels who will complete these assessments will also be available to provide advice to manufacturers and innovators on the requirements for their device early in the development process.
In addition, the provisions relating to the routine assessment of medical devices by notified bodies are clarified and in particular in relation to the notified body’s assessment of clinical data presented to demonstrate the safety and performance of a device.
5. Enhanced provisions for market surveillance
Both the MDR and IVDR further define and develop the requirements for the continued surveillance of medical devices on the market both by manufacturers and by regulatory authorities.
Manufacturer’s obligations in relation to operating effective post-market surveillance of their medical devices are more prescriptive leading to greater clarification as is the need to continuously update risk analysis and clinical documents.
The Regulations place specific obligations on regulatory authorities in relation to ensuring effective market surveillance systems are in place at national and European level. This includes increased assessment of regulatory compliance of devices, increased provisions for sampling and testing of devices and greater legal powers to address non-compliant products.
In addition the new Regulations increase the definitions and provisions relating to the reporting and assessment of adverse incidents (vigilance). Additional reporting obligations are defined for manufacturers of high risk devices including the compilation of Periodic Safety Update Reports (PSURs). Specific obligations are placed on authorities regarding the assessment and coordination of vigilance issues.
6. Governance, coordination and cooperation
To help achieve all of these improvements and ensure an effective regulatory system is implemented, the MDR and IVDR have specific requirements and structures defined to provide for governance and coordination of the system.
Throughout both Regulations the national authorities are required to work closely together in a coordinated fashion and in conjunction with the European Commission.
The European Commission’s role and functions in coordinating the system has also been significantly enhanced with obligations for the provision of administrative, scientific and technical coordination of the system. The HPRA anticipates that this will include support from the policy unit in DG Grow D4, DG Santé Unit F (Food and Veterinary Organisation) and the DG Joint Research Centre.