November/December 2020 EuroLabNews
3. Hot Topics in Laboratory Medicine
First encounter with the EFLM Task Force on European Regulatory Affairs
Reported by Christa Cobbaert and Michael Neumaier, co-chairs EFLM Task Force European Regulatory Affairs
New and far-reaching EU legislation has to be implemented in all EU Member States by May 2022: the In Vitro Diagnostic Medical Devices Regulation (IVDR). Succinctly, the IVDR will increase the requirements for clinical evidence aiming to ensure clinical benefit and safety of IVDs, including post-market vigilance. The IVDR will substantially increase the involvement of Notified Bodies, which are independent conformity assessment institutions nominated by the national competent authorities of European member states. Assessments and audits by Notified Bodies will be required under the IVDR for the vast majority of diagnostic tests (class B, C and D tests). Furthermore, this will be complemented via European Commission-nominated EU Reference Laboratories (EURLs) tasked to validate specific high-risk tests (class D tests, i.e. infectious agents and blood group testing). Laboratory Developed Tests (LDTs) are exempted from the full impact of IVDR, but are only justified in healthcare institutions, if no other equivalent tests with similar performance are on the market. Non-existence of such marketed tests has to be shown. The impact of the IVDR on commercial labs with high numbers of LDTs will be substantial as these labs will be required to CE-mark their LDTs. The implementation of the IVDR is managed by the European Commission (DG SANTE) and the National Competent Authorities, who steer several working groups under the umbrella of the Medical Device Coordination Group (MDCG). The IVDR represents both opportunities and threats for the medical laboratory and the diagnostic industry, with variable implications for private, public and commercial labs or healthcare institutions. In any case, laboratories will face strong increases of bureaucratic and administrative work generating additional workload.
Because of the huge IVDR implications for all IVD-stakeholders and patients, the EFLM Executive Board has established a Task Force on European Regulatory Affairs (TF-ERA). In this newsletter, we want to explain the organigram of TF-ERA and the tasks of the Task Force members nominated by their national societies as well as the tasks of the associated National Representatives nominated by the different European member states (Figure 1). The Task Force ERA consists of ~13 members: next to the chair and a moderator tasked with communication and moderation, there are two observers and two back-ups representing EFLM as a stakeholder in “the IVD-group” and “the Emerging Technology working group” within the MDCG of the European Commission (ERA1). Two members from MedTech Europe with expertise in regulatory affairs represent the affiliated IVD-manufacturers (ERA2). Four nominated members who cover different aspects and perspectives of IVDR such as IT & data Sciences (ERA3), methodology (clinical evidence requirements) (ERA4), the commercial lab chain perspective (ERA5) and research & innovation (ERA6). Very recently, EFLM became a regular member of the BioMed Alliance featuring numerous European clinical and scientific societies (see below). TF-ERA will install a member as liaison to BioMed Alliance to report to the chair. The EFLM TF ERA chair reports directly to the EFLM President and EFLM Executive Board. The nominated TF-ERA members and national representatives are displayed at https://www.eflm.eu/site/page/a/1653. The terms of reference of the EFLM TF ERA are specified at https://www.eflm.eu/site/page/a/1650. It is important to realize that the interaction with the EU authorities and Working Groups is extensive, multi-facetted and demands short response times and actions, thereby requiring an appropriate structure within TF-ERA.
Below, we want to give some specific insights into the major tasks: the TF-ERA observers to the MDCG working groups of the European Commission (EC) are, according to their role, “at the table” during meetings and consultations of the European Commission regarding interpretation and operationalization of the IVDR. The chair (currently 2 co-chairs) is (are) responsible for organizing the monthly virtual meetings and for setting the agenda. The moderator is responsible for drafting minutes during the EFLM TF-ERA virtual meetings and for posting relevant updates and documentation in the TF-ERA forum library, including rapid dissemination of EC guidance documents that demand consultation and input for the national representatives. The moderator also gathers the digital responses and questions from National Representatives from the forum and structures and shares these with the chair (co-chairs), at least 10 days ahead of the next virtual meeting. The other TF-ERA members and the MedTech Europe representatives will provide input on relevant aspects of the IVDR transitioning, in their roles and from the perspective they are expected to cover. All TF-ERA members bring in relevant guidance documents and summarize them effectively to enhance the efficiency of the virtual meetings. The national societies are informed monthly through their national representatives.
The EFLM TF-ERA intends to take a proactive role in the transitioning to IVDR implementation per May 2022 through its functional governance and communication structure, which aims to consult with the political implementation process of the European Commission where needed. Providing such guidance must be done through the national competent authorities of all European members states in order to guarantee a smooth and justifiable IVDR implementation. Because the medical laboratory´s work in patient care will experience a major impact by the IVDR implementation, it needs to assure to be “heard in the EC” during the implementation period. EFLM recently became a member of Biomed Alliance, a non-profit organization representing over 30 leading European research and medical societies involved in both diagnostic and therapeutic care of all EU citizens. BioMed Alliance has a long-standing and acknowledged expertise in regulatory aspects of Medical Devices. With TF-ERA, EFLM contributes an important expertise to the IVD arm of medicine within the EU regulatory frameworks. Indeed, EFLM is geared up to contribute expertise through several WGs, TFs sand TFGs.
Specifically, TF-ERA reaches out to existing EFLM working groups and committees working on related content, among them the EFLM Working group on Test Evaluation (WG-TE), the EFLM Quality and Regulations committee (C-QR) and the TF for Disruptive Technologies (TF-DT). In essence, TF-ERA will share regular updates on the availability of essential infrastructure that is needed for proper IVDR implementation (such as Notified bodies, European Reference Laboratories, Expert Panels and a contingency plan) as well as guidance documents from the European Commission that have to be commented upon at short notice. To reach out quickly to all European National Societies through the nominated national representatives, the digital TF-ERA forum has been set up (https://www.eflm.eu/site/page/a/1650) and is now operational. Access to the TF-ERA forum is restricted to TF-ERA members. National representatives provide a direct conduit to their respective National Societies and are expected to take responsibility for the communication with their professional societies or national competent authorities. The ultimate goal of the EFLM TF-ERA activities is to guarantee EU-wide uninterrupted access to clinically effective, affordable and safe medical tests.
With 18 months to go until the application date of the IVDR, the clock is ticking for its implementation, and there are numerous important issues still to be addressed. So far, the European Commission did not officially react on the Calls for Action from BioMed Alliance and MedTech Europe. Both organizations recently called on the European Commission to address their concerns about various delays related to the implementation of the IVDR (EU 2017/746). If the European Commission has insufficient capacity to meet the concerns of the diagnostic health sector, then the date of application of the IVDR should be postponed. Other calls for specific actions by the European Commission relate to the necessity of having EU-wide derogations for medical testing in case of crisis management -such as the COVID-19 outbreak, and to have assurance about appropriate implementation of the IVDR for LDTs. Last week a long-awaited guidance document from the MDCG of the EC on the risk-based Classification of Medical Tests has appeared and is now available. I.e. MDCG 2020-16, entitled: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
November 2020. The full guidance document can be approached at https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020_guidance_classification_ivd-md_en.pdf. The deadline for sending comments is 30 November 2020.
In conclusion, TF-ERA is a multi-national Working Group interconnecting with diagnostic and clinical societies to assist in smooth transition of laboratory tests during the implementation phase of the EU IVDR. We believe that it is essential to warrant adequate laboratory testing and diagnosis in the interest of patient safety and improved patient outcome under an active EU-wide IVD regulation.