February 26, 2021Sherri Fraser, PhD
How has COVID-19 affected IVDR compliance processes?
“Given how COVID-19 has brought the EU’s IVDR implementation progress to a halt, compounding on the challenges that already existed, the remaining IVDR transition time is not tenable and urgently requires attention and solutions,” said Serge Bernasconi, CEO of MedTech Europe, from MedTech Europe’s Statement Industry reinstates its call for solutions to ensure a workable transition to the new regulatory frameworks for medical devices and in vitro diagnostics, Oct. 2020
COVID-19 monopolizes resources
The EU’s new IVDR (in vitro diagnostic regulation) applies to all new in vitro diagnostic (IVD) devices, but also to all IVDs currently conforming to the 1998 in vitro diagnostic medical devices directive (IVDD). Hence, almost all existing, certified IVDs will require recertification before the application deadline of May 26, 2022. The only exceptions are those that received certification during the transition period and they will only be certified to no later than 2024.
Conformity of many in vitro diagnostic (IVD) devices, under the EU’s new IVDR (in vitro diagnostic regulation) requires testing and consultation with Competent Authorities (CAs) or the European Medicines Agency (EMA). Under the pandemic, many of the lab facilities and all the CAs and the EMA have their hands full simply managing the testing and reporting for the pandemic.
Manufacturers have been rising to the COVID-19 challenge, shifting to making PPE and other testing, cleaning, or medical equipment in short supply. This means they have not been able to focus their attention on completing the needed applications, technical documentation, QMS (quality management systems), testing, and more required to bring their current products into compliance. They also have not been able to give adequate attention to the testing and development of new IVDs.
Shutdowns affecting actors, regulators, and notified bodies
All elements of the manufacturing, import, and conformity compliance requires people. With many countries in lockdown and staff quarantining at home, there are far fewer people to do the work needed to keep the processes going. Further, with people either having to social distance at work, which reduces staffing, or trying to shift to working from home, the hours it takes to complete the tasks grows. This disruption hits every aspect of the IVDR conformity process.
MDR application deadline extension impacting IVDR compliance
In April 2020, the European Commission pushed the application deadline for the MDR (medical devices regulation) off by a year, due to the impact it was already seeing from COVID-19. The MDR, to regulate medical devices, was established at the same time as the IVDR. The processes and many notified bodies overlap between the two regulations, so the delay in the application deadline for MDR will have a direct impact on the implementation of IVDR. Much of the MDR work will be pushed closer to the IVDR application date, leaving less time for the notified bodies and actors to meet that IVDR application date.
IVDR implementation concerns existed before COVID-19
MedTech Europe, Europe’s medical technology trade association, has been calling for the European Commission and member states to open discussions to address concerns regarding the deadlines in the IVDR for years.
Notified body workload dwarfs capacity
As of December 2020, there were only five notified bodies qualified to help guide the IVDR conformity process for manufacturers, and one of those was only recognized in November 2020. As far back as 2018, MedTech Europe was raising concerns about the lack of notified bodies to do the work of certifying about 45,000 IVDs. The concerns about the pressure on notified bodies and the Commission’s slow creation of new notified bodies are only amplified by COVID-19.
EU lacks infrastructure to conduct conformity assessments
Common specifications missing
Aside from only five notified bodies currently available, there are other significant infrastructure components missing to help complete IVD conformity. MedTech Europe published a position paper, highlighting missing pieces needed for conformity. Among the gaps are common specifications for devices that detect infectious agents like HIV, which will not be in place until the second quarter of 2021. Without these harmonized standards, there is no legal framework for the manufacturers to understand what they need to do to comply with the regulation. Such a set of common specifications are also going to be required for COVID-19 diagnostics.
Expert oversight still missing
Some of the critical reasons the IVDR is replacing the IVDD were to improve oversight, scrutiny, transparency, and monitoring. Many of these tasks rely on the input of experts.
Twelve panels, made up of experts in the field, will provide support, scientific assessment, and advice on IVDs. The call for experts only went out late in 2019 and the first expert panels were not expected until the end of 2020. However, as of early January 2021, there have been no press releases indicating any panels have been established. These panels are critically needed, as one of their defined roles is to identify emerging issues and concern regarding IVDs. Without their expertise, these issues will be left unaddressed, including anything regarding COVID-19 diagnostics.
EU reference laboratories (EURLs)
The establishment of EURLs is planned for after the launch of the expert panels. EURLs will test performance claims made by manufacturers of IVDs. Without these labs and their testing, no class D IVDs can be certified. These performance tests can take months to complete and with the 2022 deadline looming, there is a very real risk that many of the Class D IVDs, such as those for testing for COVID-19, will not have their CE stamp of approval. This could leave the EU in a position where their medical system does not have access to tests needed to protect their population.
Progress on the IVDR front
MDR exceptions and application deadline delay
The medical devices regulation (MDR) was first published at the same time as the IVDR, in April 2017, but with a shorter, three-year timeline to implementation. Last April, the European Commission extended the date of application from May 2021 to May 2022, due to the pandemic. Before that, the Commission published a corrigendum in 2019 confirming that some class I medical devices were exempt from compliance with MDR until 2024, giving those manufacturers more time to complete the conformity process. MedTech Europe is calling for the European Commission to open discussions regarding similar updates to the IVDR implementation.
One of the largest concerns about COVID-19’s impact on the conformity process is that in-person audits are almost impossible. With borders closed and close contact discouraged, if not outright banned, inspectors are unable to complete the required audits of manufacturing facilities. Some virtual audits were allowed early in 2020, but in December, the European Commission published the MDCG 2020-17 Questions and Answers related to MDCG 2020-4 from the Medical Device Coordination Group. This document provided some much-needed guidance about which circumstances allow virtual audits during the COVID-19 pandemic.
Actors module active on EUDAMED
EUDAMED, the Commission’s interconnected database, will be the depository for all documentation relating to the IVDR. The first of the six modules, the actors module, became active in December 2020. This module will allow manufacturers, authorized representatives, producers, and importers to register with the European Commission as actors. However, there is no current timeline for the activation of the other five modules.