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Key aspects of Medical Device Regulation (MDR) and common In-vitro diagnostic medical device Regulation (IVDR) aspects

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:

made based on experience of implementing the existing Directives since the mid-1990s;
to address identified gaps or weaknesses in the existing system;
and in light of technological and regulatory developments in the medical technology sector.

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.

HPRA INFOGRAPHIC - Potential EU governance model for device regulation as per new Regulations (©HPRA)

Significant improvements in coordination of the regulatory system have been made over the last number of years by the Competent Authorities for Medical Devices (CAMD) network. The CAMD allows for a close cooperation between all of the regulatory authorities responsible for medical devices across Europe and the European Commission. Further information can be found at www.camd-europe.eu.

The CAMD will also serve as a forum for coordination on implementation on these new EU Regulations at European level and help ensure each authority takes a consistent approach. The CAMD will also provide opportunities for a common communication on the new Regulations by EU authorities and the EU Commission.

The first stakeholder day on the new Regulations, arranged jointly by the CAMD and EU Commission was held in Brussels on the 9^th March 2017. Please find The EU Commission’s presentation from this stakeholder day. We wish to thank the EU Commission for allowing us to publish this presentation.

In addition to the improvement across these range of fundamental aspects of the regulatory system for devices other significant developments and improvements have been made, including but not limited to:

Requirements for every economic operator involved in the medical device sector are clearly defined. Both the MDR and IVDR place very specific obligations on operators throughout the supply chain, including distributors and importers, of a medical device to help ensure that products placed on the EU market are compliant and that any issues are addressed as effectively as possible, thus helping to secure the integrity of the supply chain. Increased information will be available about economic operators to clearly identify their role in the supply chain. A detailed series of specific obligations and requirements are defined for medical device manufacturers including an overview of the components to include in their obligatory quality system.

Both new Regulations require that each device must have a unique identifier. This will facilitate the availability of clear information on all of the devices available on the European market place and the ability to identify all of the manufacturers and other economic operators responsible for them. These details will be contained within a centralised European database which the public and healthcare professionals will also be able to access leading to improved transparency. These requirements will also enhance the traceability of devices in the event that a device needs to be modified or recalled from the market.

The MDR will also have a broader scope and include more products which have previously not been regulated as medical devices. In particular, the legislation will regulate invasive and implanted devices used for aesthetic and cosmetic purposes such as dermal fillers and coloured contact lenses. The aim of the legislation is to try to ensure these devices are as safe as possible and that people are aware of the risks associated with using such products.