The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU.
Increased regulatory oversight, expanded clinical evidence requirements, greater requirements for IVD manufacturers and intensified supervision of Notified Bodies are just some of the major changes to be considered as compared to the EU’s previous Directives: the Active Implantable Medical Devices Directive (AIMDD), Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD).
This increased oversight will require manufacturers to make significant changes in product development, data reporting and quality assurance. As a result, device manufacturers can expect higher costs and longer timelines for developing new products, as well as costly new clinical monitoring and evidence generation to recertify many existing products. The regulations will take effect across all member EU states, profoundly affecting business models of all medical and diagnostic device companies within the world’s second largest device market. Here, we outline the top four challenges faced by manufacturers under the new EU regulations, and how ensuring compliance early can lead to maximum success.
Reclassified and up-classified devices
Under the MDR and IVDR, changes will be made to the way that medical devices are classified, with requirements being increasingly scrutinised based on risk posed to patients. 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. Both the new MDR and IVDR move from focusing on product approval to the entire product lifecycle, requiring greater clinical evaluation before approval. This will undoubtedly slow device production significantly.
Elevated clinical testing requirements
Another leading challenge faced by manufacturers under the new EU regulations is an increase in clinical testing requirements. Due to reclassification of IVDs, manufacturers that have not previously been required to perform clinical testing will have to develop the ability to do so. Furthermore, the clinical evidence required for IVDs is more complex than that of many other medical devices. These two factors, combined, will require a great deal of additional time, money and expertise.
For medical devices, the new regulations require reassessment of clinical data for devices already on the market. If the data do not meet the new requirements, devices will be required to undergo additional testing to be recertified, increasing the expense of maintaining legacy devices.
Increased demand on Notified Bodies
Until now, notified bodies (NBs) have filled a consultative role to help manufacturers meet CE mark requirements. Now, under the new MDR and IVDR, NBs will serve as enforcers of the new regulations, evaluating all medical devices (excluding IVDs) above Class I and IVDs above Class A. This accounts for approximately 90% of all IVDs, up from about the previous 1%, which 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. The bottleneck created by fewer NBs with higher workloads could lead to long delays before the review process can even commence.
Emphasis on post-market surveillance
Finally, under the new IVDR and 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 pace and frequency of safety and performance reporting may require significant additional resources for device and diagnostic companies, these requirements can better spot potential issues early in the production cycle. Addressing them can protect patients and reduce manufacturer liability.
Ensure compliance early
Early transitions to new regulations will be critical in giving products an edge in the market. You can get ahead of the competition by adhering to the following solutions:
- Implement a strategic approach early on to ensure compliance and make products more attractive to value-conscious buyers
- Seize the opportunity to audit portfolios and eliminate unprofitable products
- Partner with a CRO to harness its regulatory expertise
These solutions can help medical device and diagnostic companies to begin planning immediately and ensure compliance early. Adjusting will take time, funding and effort – and is critical for future success.
Here’s a complete list of EU MDR and IVDR Guidance Documents (with PDF Download Links)
Clinical investigations and evaluation
- JUL2020 [MDCG 2020-13] – Medical device clinical evaluation assessment report template
- MAY2020 [MDCG 2020-10] – Safety reporting and clinical investigations
- APR2020 [MDCG 2020-8] – Medical device PMCF evaluation report template
- APR2020 [MDCG 2020-7] – Medical device PMCF plan template
- APR2020 [MDCG 2020-6] – Gathering sufficient clinical evidence for legacy devices
- APR2020 [MDCG 2020-5] – Medical device equivalence in clinical evaluation
- AUG2019 [MDCG 2019-9] – Summary of safety and clinical performance
Unique device identification (UDI)
- JUN2020 [MDCG 2018-3 V1] – Guidance on UDI for systems and procedure packs
- MAR2020 [MDCG 2018-1 V3] – Guidance on basic UDI-DI and changes to UDI-DI
- FEB2019 [MDCG 2019-2] – Application of UDI to combination devices noted in MDR Article 1(8, 9, 10)
- OCT2018 [MDCG 2018-6] – Clarification of UDI responsibilities for Economic Operators
- OCT2018 [MDCG 2018-5] – UDI assignment to medical device software
- OCT2018 [MDCG 2018-4] – UDI core elements for systems or procedure packs
- JAN2020 [PDF] – Understanding the classification structure of EUDAMED
- APR2019 [MDCG 2019-5] – Registration of legacy devices in EUDAMED
- APR2019 [MDCG 2019-4] – Clarification on registration timelines for devices in EUDAMED
Software and cybersecurity
- JUL2020 – [MDCG 2019-16 V1] – Cybersecurity of medical devices
- MAR2020 [MDCG 2020-1] – Clinical evaluation/performance evaluation of medical device/IVD software
- OCT2019 [MDCG 2019-11] – Qualification and classification of medical device and IVD software