New regulations are in effect, with transition periods ending in 2020 and 2022
Medical and in vitro diagnostic device manufacturers in the EU are likely aware of big changes in motion. Two new regulations – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – were adopted in 2017, with initial transition periods provided for device manufacturers to come into compliance.
What aspects of medical device product portfolios will be affected?
- The collection of clinical evidence
- Post-market surveillance procedures
- Increased product transparency for consumers, competitors, and other notified bodies
Strategic implications for device manufacturers
Medical device manufacturers should start planning their compliance approach now. There will be many steps to complete over the coming two years to ensure compliance. Device manufacturers will need to review their current strategy and make investments in new areas of the business.
Some high-level actions necessary for an effective compliance will include the following:
- Engage top management and raise awareness of the impact of this new regulation in all aspects of the business – Regulatory teams will not be able to comply with this new regulation without involving other key stakeholders (e.g., clinical, manufacturing, commercial excellence, operations, safety) to understand and assess the full impact and clearly set the company transformational strategy and objectives.
- Perform a gap assessment to determine compliance gaps against the new MDR and set a clear plan to support a smooth transition and ensure business continuity
- Conduct due diligence around MDR readiness with partners, notified bodies, and suppliers
- Identify the total cost of compliance and the resources allocation to support the transition (e.g., rationalizing the product lines accordingly, creating new roles to support these cross-functional activities)
- Invest in regulatory systems and IT infrastructure for data management and establish structured systems to collect, maintain, and exchange the required data
What drove the EU Commission to create the new regulations and what are the expected improvements?
According to the EU Commission, “Problems with diverging interpretation of the current Directives as well as (an) incident concerning fraudulent production of the PIP silicone breast implants,” drove them to review medical device regulations. The goal of the new regulations is to bring a number of improvements for medical and in vitro devices:
- Improve the quality, safety, and consistency of medical devices (e.g., by reinforcing the rules on clinical evidence, including an EU-wide coordinated procedure for authorization of multi-center clinical investigations)
- Reinforce transparency of information for consumers through the establishment of a comprehensive EU database on medical devices and of a device-traceability system based on Unique Device Identification
- Enhance vigilance and post-market surveillance via an improved coordination system between EU countries for data exchange
When do the regulations go into complete effect?
While adopted and placed into force in 2017, the new regulations allow for a transition period – three years from entry into force for the regulation on medical devices (Regulation (EU) 2017/745) and five years from entry into force for the regulation on in vitro diagnostic medical devices (Regulation (EU) 2017/746). This means the current transition periods will end in 2Q 2020 and 2Q 2022 respectively.
Figure 1: EU regulations for MDR and IVDR: Placing a device on the market under the new Regulations
The key objective of the new EU MDR is to ensure a high level of health and safety protection for EU citizens by:
- Making the clinical evaluation more stringent
- Strengthening of Post-Marketing Surveillance
- Improving transparency via the European database
Clinical evidence is certainly not a new requirement and using clinical justification based on device equivalence has been a standard for years under the existing Medical Devices Directive (MDD). The new MDR outlines new clinical investigation requirements and requires manufacturers to show that the device has the same technical, biological, and clinical characteristics and demonstrate having sufficient access to the data on that equivalent device.
In addition to these new clinical evaluation reports, a public summary of safety and clinical performance is required for some types and classes of devices, and clinical data derived from clinical investigations (following Good Clinical Practice (GCP)) conducted under a sponsor’s supervision will also be required for Class III and implantable medical devices.
Requirements for post-market surveillance already exist with the MDD as well; however, there are significant changes with MDR. A key change is a reduction in the time for adverse event notification – from 30 days to 15 days. The new regulation also includes post-market surveillance plans for Class II and III medical devices requesting submission of post-market clinical follow-up (PMCF) and Periodic Safety Update Reports (PSUR).
The European Database on Medical Devices
The European Database on Medical Devices was previously initiated with the aim to help European authorities conduct market surveillance on medical devices through information exchange. With the advent of MDR, this database is required to include a wide range of new data points – including product and registration information, clinical evaluation summaries, and post-market data. The MDR also extends access to the database to manufacturers, suppliers, and authorized representatives, not just authorities and notified bodies. This change will lead the industry in the same direction as the SPOR master data for the Identification of Medicinal Products (IDMP).
To learn more about these Medical Device Regulation changes and how you can best prepare to comply, contact Jens-Olaf Vanggaard.