The Regulation (EU) 2017/745 relating to medical devices, which amends Directive 2001/83 / EC (Community code relating to medicinal products for human use), Regulation (EC) n. 178/2002 (food safety) and regulation (EC) n. 1223/2009 (cosmetics) and repealing directives 90/385 / EEC (active implantable medical devices) and 93/42 / EEC (medical devices), entered into force on 25 May 2017. It applies from 26 May 2020.
The reasons that led to the revision of the regulatory framework and the adoption of a new regulation are essentially two:
- Serious scandals due to deficiencies in terms of compliance with the minimum requirements for the production and marketing of medical devices (eg PIP scandal, and cobalt chrome prostheses)
- Enormous technological advances over the last 20 years that require a continuous updating of the regulatory framework
This long-awaited regulation brings greater control of the technical documentation; addresses concerns related to safety assessment and product performance putting strict requirements on clinical evaluation and post-market clinical follow-up and requiring better device traceability across the entire supply chain.
The most significant variations of the proposed regulation
- Purpose Expansion – The definition of medical devices and active implantable medical devices covered under the MDR will be greatly expanded to include devices that have not a medical destination, such as colored contact lenses. Devices designed for a specific disease or health condition should also be included in the scope of the regulation.
- Increased clinical evidence – The MDR will require manufacturers to conduct clinical studies on the performance of each specific device and prove its safety and performance based on the risk associated. Device manufacturers will also be required to collect and store post-market clinical data as part of the ongoing assessment of potential safety risks.
- Identification of the “qualified person” – Device manufacturers will be required to identify at least one person within their organization who will be responsible for all aspects regarding compliance with the requirements of the new MDR. The organization will also have to document its specific qualifications with respect to the tasks required.
- Implementation of Unique Device Identification (UDI – Unique Device Identification) – The new proposed MDR imposes mechanisms for the unique identification of the device (UDI). This requirement is expected to increase the manufacturer’s ability in the traceability of devices in the supply chain, and to facilitate manufacturers in quickly and efficiently recalling medical devices that present safety risks. Furthermore, the European medical device database (Eudamed) should be expanded to provide more information on approved medical devices.
- Strict post-market supervision – The new MDR will guarantee notified bodies greater authority in post-market surveillance. Unannounced audits, tests and sample checks will strengthen the application system in Europe and thus help reduce the risks arising from unsafe devices. In many cases manufacturers will also be required to report annually on safety and performance.
- Technical characteristics – The new MDR requires the European Commission or groups of experts (yet to be defined) to publish Common Specifications, which must be taken into consideration by manufacturers and notified bodies. These Common Specifications must exist in parallel with the harmonized standards and the State of the Art.
Time may be the most challenging aspect of the transition to the new requirements. Three years may seem like quite a long time, but there is much to do. Just fully understanding the MDR, conducting the gap assessments and analyses needed to identify where more work is required and plotting a course to compliance is quite time consuming itself, therefore PLAN AHEAD is necessary.
KEY POINTS: Planning, reclassification and post-market surveillance
Manufacturers should initiate a plan to assess all of their current CE marked devices relative to the new MDR guidelines. For some products, this also means considering changes in classification.
Changes will be made to the way that medical devices are classified, with requirements being increasingly scrutinised based on risk posed to patients. It follows a more restrictive classification and therefore a class increase for many devices (for example, certain devices that come into contact with the spinal cord will move up from class II to class III).
Reclassification of devices will require costly certification processes for new products as well as recertification of products already on the market. It should not be taken for granted that for a device that has not been reclassified, the steps to ensure that it remains compliant will be quick or simple.
MDR vs MDD
Understanding what has changed between the existing Medical Devices Directive 93/42/CEE and Active Implantable Medical Devices Directive 90/385/CEE and the MDR is critical as it is highly probable for most devices that a review of Annex I, General Safety and Performance Requirements,will identify new conditions that will need to be addressed for every device.
Clinical data, technical documentation and labeling will need to be updated. Also, it will be necessary to revisit processes including safety and performance general data, the quality assurance, clinical trials, risk management, general compliance and clinical post-market follow-ups that will require careful review, planning and updating to re-implement in compliance with new requirements.
With MDR there will be an increased emphasis on post-market surveillance. This includes proactively monitoring device performance for recertification, annual safety updates for higher-risk class devices, and rapid reporting of safety incidents.
While the increased frequency of safety and performance reporting may require significant additional resources for companies, these requirements can better spot potential issues early in the production cycle. Addressing them can protect patients and reduce manufacturer liability.
By the end of the transition process, every CE marked device must by fully compliant with the MDR. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has estimated that more than half a million different devices currently CE marked under the Directives 93/42/CEE and 90/385/CEE must transition to fully comply with the MDR.
While many MDR requirements are similar to current state-of-the-art requirements under the MDD (Medical Devices Directive) and the AIMDD (Active Implantable Medical Devices Directive), the MDR is much more prescriptive and many devices will not have been fully evaluated against the newest requirements.
Under the MDR, there is much greater emphasis on more thorough reviews by Notified Bodies to confirm manufacturers are fully compliant and devices are fully supported by adequate data and technical documentation.
Notified Bodies role
Until now, notified bodies (NBs) have filled a consultative role to help manufacturers meet CE mark requirements. Now, under the new MDR, NBs will serve as enforcers of the new regulations. This will increase NB workloads and decrease NB availability.
The decrease in availability of NBs to review devices, particularly in higher risk classes, will delay product approvals and slow device entry-to-market. Additionally, with NBs now being required to review a greater volume of data, timelines will be lengthened, increasing overall costs in the device pipeline. Fewer NBs with higher workloads could lead to long delays before the review process can even commence.
As of today, we know that Notified Bodies will not be allowed to apply for designation under the MDR before November 2017, and the designation process could take 12–18 months or more to complete, meaning that the effective transition window will be significantly reduced.
Many Notified Bodies currently designated under the MDD may not achieve designation under the MDR, or may decide not to apply for the designation. It is possible that some Notified Bodies may feel confident to begin conducting some conformity assessment work with manufacturers before designation, which may provide some valuable lead time to get ahead of late transition bottlenecks.
In any case, it is strongly recommended that you start early and work with committed long-term Notified Bodies to confirm common expectations, and submission and assessment timetables.
Here are some guidelines for implementing the new medical device regulation.
Documents and guidelines of the European Community and Notified Bodies
Implementation of Medical Devices EU-Regulation – Focus on Manufacturers’ obligations
Implementation Model for Medical Devices Regulation Step by Step Guide
Fact Sheet for Manufacturers of Medical Devices
Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step Guide
Fact Sheet for Manufacturers of In-Vitro Diagnostic Medical Devices
TÜV SÜD – Fact Sheet
MHRA -MDR – IVDR Guidance
Understand all the news and requirements introduced thanks to the following Live Webinars:
– Regulation 745/2017 on Medical Devices: main changes and timeline to implementation
– Regulation 745/2017 on Medical Devices: obligations of the economic operators, from Eudamed registration to Responsible person
– Regulation 745/2017 on Medical Devices: Unique Device Identification
– Regulation 745/2017 on Medical Devices: Technical File structure
– Regulation 745/2017 on Medical Devices: Post Market activities and follow up