Many firsts as deadlines draw closer, yet bottleneck concerns remain
Less than one year remains before the European Union’s new Medical Device Regulation (MDR) goes into effect on May 26, 2020, and only about a fourth of medical device companies plan to be fully complaint, according to a report by the Regulatory Affairs Professionals Society and KPMG. One of the major challenges to reaching full compliance by the deadline are notified body (NB) capacity shortages.
While Vytenis Andriukaitis, the European Commissioner for Health and Food Safety, expects around 20 NBs to be designated before the end of 2019, there remains a great deal of uncertainty about whether companies will be able to find a NB to certify their devices. Only five NBs are currently certified to review devices under the new MDR regulation, and designation of NBs has lagged overall, with several exiting the sector.
Moreover, until recently, no NBs had been designated under the new In Vitro Diagnostic Regulation (IVDR), creating a barricade to any in vitro diagnostics (IVDs) entering the EU market under the new rules. Now, with only one designated NB (see below), the capacity to assess IVDs under IVDR may be inadequate to meet the demand before the May 2022 deadline, creating bottlenecks that could result in product shortages. Below, we summarise recent updates.
New NB designations under MDR
TÜV Rheinland became the fifth notified body designated under MDR, after Instituto Italiano del Marchio di Qualita S.P.A. (IMQ), BSI Assurance UK Ltd, TÜV SÜD Product Service GmbH and DEKRA Certification GmbH. Further, not all of these NBs are designated to certify all device classifications, therefore, more designations are needed to ensure adequate NB availability and European market access for manufacturers.
First two NBs designated under IVDR
In October, DEKRA became the first NB designated for the IVDR, shortly followed by BSI. The UK-based NB stated it is the first NB to achieve full scope designation, which covers all devices for IVDR, including new categories of devices that were not covered by previous directives such as genetic tests and companion diagnostics.
Until recently, the lack of NBs designated to review IVDs caused a complete roadblock to marketing these products under the new regulation. Under the existing directives, most IVDs could self-certified, with less than seven percent of IVDs requiring NB certification. That number is projected to increase to nearly 85 percent under IVDR. Currently, there are nine additional NBs in the process of designation, although doubts still remain whether all IVDs on the EU market will be able to obtain certification by the May 2022 deadline.
First device certified under EU MDR
The Novartis Concept1 inhaler became the first certified product under MDR through BSI, in September. Previously, the inhaler was classified as a Class I device, and did not require review by an NB. It is now classified as a Class IIa device. This is one example of hundreds of devices that will need to undergo NB review under MDR, adding to growing backlog of submissions.
New EU regulations call for UDI numbers
An important aspect of the new regulations is the creation of an identification system based on unique device identifiers (UDIs) to improve product traceability, reduce medical errors and facilitate accurate reporting of adverse events. Earlier this summer, the European Commission designated four supply chain standard organisations as issuing entities for UDIs: GS1, Health Industry Business Communications Council (HIBCC), International Council for Commonality in Blood Banking Automation (ICCBBA), and Informationsstelle für Arzneispezialitäten. The new rules require that a UDI number be applied to the medical device label, packaging or device itself. In addition, product data must be submitted to European Database on Medical Devices (Eudamed) to help enforce the safety and performance requirements of the regulations.
Classifying software under MDR, IVDR
The European Commission’s Medical Device Coordination Group (MDCG) released guidance to help medical software manufacturers understand necessary criteria for the qualification of software under the MDR and IVDR. The guidance details examples of software that would be classified under MDR or IVDR, including software that can control, operate, or modify the state of a medical device, provide immediate decision-triggering information, or provide support for health professionals.
Eudamed delayed until 2022
European Commission officials confirmed plans to delay the implementation of Eudamed, pushing the date from March 2020 to May 2022 which coincides with the implementation date for the In Vitro Diagnostic Regulation, set to take effect May 26, 2022.
To ensure compliance under MDR and IVDR before rapidly approaching deadlines, manufacturers should act quickly to identify and secure a NB. Manufacturers should evaluate expertise and resources to determine which NBs are the best fit for their products. Additionally, manufacturers should expect a queue for NB review of clinical evidence and, therefore, should plan to engage with NBs early to discuss timelines to avoid bottlenecks and delays. Moving forward, manufacturers may benefit from the expertise of a strategic partner that can provide support in navigating increasingly complex regulatory landscapes.