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qtec group | Scientific Advice from the Medical Device Expert Panels on SARS-CoV-2-IVDs| qtec-group

Scientific Advice from the Medical Device Expert Panels on SARS-CoV-2-IVDs

Summary

Background and Purpose

The Medical Device Coordination Group (MDCG) requested scientific advice from the European Medicines Agency (EMA) to re-evaluate the classification of SARS-CoV-2 in the context of in vitro diagnostic medical devices (IVDs). This advice aims to determine whether SARS-CoV-2 still meets the criteria for being classified as a life-threatening disease and a high-risk infectious agent, considering the evolving epidemiological context of COVID-19.

Key Findings

Epidemiological Context

SARS-CoV-2 was declared a pandemic in March 2020, initially causing high mortality rates and severe outcomes.

Over the past four years, the epidemiological landscape has changed significantly due to:

  • Widespread immunity from vaccinations and prior infections
  • Emergence of less pathogenic variants, particularly Omicron and its descendants
  • Improved treatment strategies and public health measures

Current Classification Assessment

  1. **Life-Threatening Disease:**
    • SARS-CoV-2 no longer meets the criteria for causing a life-threatening disease in the general population.
    • Reduced severity and mortality rates are observed, particularly with current Omicron variants.
    • However, it remains a serious risk for vulnerable groups (elderly, immunocompromised, those with underlying conditions).
  2. **High-Risk Infectious Agent:**

    SARS-CoV-2 continues to be classified as a high-risk infectious agent due to:

    • High transmissibility and rapid spread
    • Potential for new variants to emerge and evade existing immunity
    • Ability to spread among asymptomatic individuals

Implications of Erroneous Diagnostic Results

For the general population:

False negatives may delay treatment and increase transmission risk but are unlikely to cause severe outcomes. False positives may lead to unnecessary isolation or treatment, causing inconvenience rather than life-threatening consequences.

For vulnerable populations (e.g., pregnant individuals, elderly):

Erroneous results can have more significant implications, potentially leading to delayed treatment or unnecessary interventions. The risk of severe outcomes or death from diagnostic errors is considered low but higher than in the general population.

Recommendations

  1. Re-evaluate the classification of SARS-CoV-2 IVDs based on the current epidemiological context.
  2. Consider adjusting the risk classification of IVDs from Class D (highest risk) to a lower risk category, depending on specific device types and use cases.
  3. Maintain regulatory preparedness for potential emergence of new, highly virulent variants.
  4. Focus on protecting vulnerable populations through targeted diagnostic and public health strategies.
  5. Conduct periodic reviews of SARS-CoV-2 classification and risk assessment based on new epidemiological data and scientific evidence.

Conclusion

While SARS-CoV-2 remains a significant public health concern, its classification and associated risks need continuous evaluation. The virus no longer causes life-threatening disease at significant levels in the general population but remains a high-risk infectious agent due to its transmissibility and potential impact on vulnerable groups.

Our recommendation

Assess the impact of this newly provided scientific advice on your devices on the market and check if there is any influence on the regulatory strategy for your device. This is also valid for SARS-CoV2 products which are not yet available under IVDR (Regulation (EU) 2017/746) but are still provided as legacy devices using the transition time. In case you need any support, we are pleased to help. In any case you have to contact your Notified Body to ensure smooth adaption. Important is the message that devices can continue to be marketed under their current risk class, provided they meet all necessary requirements for that risk class, such as batch testing according to Article 100(2)(b) of Regulation (EU) 2017/746.

Background information

“Who is who on the regulatory playground”

European Expert Panel

Recital 53, IVDR refers to class D high risk IVD for which no CS exist and at the same time first certification for that specific type of device is aimed. Scrutiny by European Expert Panel (EP) on the performance evaluation report should help to harmonize evaluation of these devices based on scientific and technological expertise of the panel members. Article 48 [6], IVDR is the legal basis of conformity assessment of some class D devices that requires this kind of scrutiny process.

Novel devices

The requirement is limited to ‘novel’ class D devices. Such devices are defined as class D devices for which no Common Specifications exist, where it is the first certification for that specific type of device, as well as that there is no similar device on the market having the same intended purpose and are based on similar technology. Within the article, there is a reference to the MDR article 106 “Provision of scientific, technical and clinical opinions and advice”. Implementing acts allow the commission to designate expert panels for the assessment of the clinical evaluation [for IVD it refers to clinical performance evaluation] in relevant medical fields. This focuses on devices with specific hazards that require “highest scientific competence, impartiality, independence and transparency” [Article 106[1], MDR]. Furthermore, the article contains specific additional requirements on the designation process, the availability of information on the panels to the public and requirements on expert laboratories in the field of physico-chemical characterization, or microbiological, biocompatibility, mechanical, electrical, electronic or non-clinical biological and toxicological testing.

Implementing act

The implementing act was set up in September 2019 when 12 panels have been defined with the 12th about the in vitro diagnostic medical devices. On 23rd of July 2023, the European Commission published the 5th version on rules of procedure of the European Commission Expert Panel on medical devices (EXPAMED). This publication describes the principles of expertise, independence, impartiality, and objectivity as well as the organizational structure, roles and responsibilities and operations. In addition to the requirement on huge scientific expertise, it is of great importance to ensure that an independent, objective assessment takes place. To this end, a specially established secretariat not only receives the panel members' CV and Declaration of Interests (DoC), but also checks for each individual case which experts can be used and that they really have no conflict of interest performing the review. The Secretariat plays a central role as they also organize the Expert Panel members within their roles as Chairs, Vice-Chairs, and advisors who are part of the so-called Screening Panel. [In March 2022, the Secretariat of the Commission’s Expert Panels on medical devices and in vitro diagnostic medical devices has been handed over from the Commission’s Joint Research Centre (JRC) to the EMA. This is part of the extended mandate of EMA on crisis preparedness as of Regulation (EU) 2022/123]. Communication is preferably performed by E-Mail or – upon request by the Chair – by a remote conference organized by the Secretariat. The latter may also organize meetings on the EMA´s premises.

The three scenarios of Expert Panel consultation

Consultations or requests on Expert Panel advice can be made in three different scenarios: The first one is consultations on performance evaluations in the context of conformity assessment. It is an obligation for Notified Bodies to ask for an EP consultation for certain class D devices. In September 2022, the MDCG updated its guideline on clarification of decision process to be performed by the NB. According to the regulation, the manufacturers Performance Evaluation Report (PER) is provided to the Secretariat within 5 days from receipt. The Secretariat performs completeness checks and defines an ad hoc expert group considering individual workload, expertise, and potential conflict of interest. As outlined before, it is mandatory for class D devices where no common specifications (CS) are available, and the application is aiming the first certification of that type [Article 48 [6], IVDR]. As EUDAMED is not fully functional, EP decisions and ongoing scrutiny processes are available on a dedicated EU database where a list of views and ongoing consultations under the “Performance Evaluation Consultation Procedure” (PECP) is provided.

Each report is structured according to a standardized scheme and comprises three chapters: administrative information, information provided by the NB and the final assessment of the EP. For all consultation procedures there is a four-eye principle with at least one Rapporteur and one Co-Rapporteur responsible for drafting the final scientific opinion. Details of the process are published within the Rules of Procedure as mentioned before.

There are two more requests for expert panel´s advice-scenarios established. One is directly related to the European Commission or the MDCG asking for scientific advice on dedicated topics, and one is from medical device manufacturers. The latter refers to class III devices according to article 61 [2], MDR, respectively to class IIb devices referred to 54[1]. The manufacturer may consult an expert panel for reviewing the manufacturer's intended clinical development strategy and proposals for clinical investigation. The request must be provided using an electronic platform and specified documents. There is no direct contact between manufacturer and EP at any time of the process. Also, the exchange with the NB is restricted to documents provided by the Secretariat.

The rationale for involvement

The overall scope of the involvement of the EP is to ensure a harmonized evaluation of high-risk devices and the development and maintenance of guidance and of Common Specifications on categories of devices that have undergone such a consultation process. MDCG and — where applicable — the Commission of the EU can also request scientific advice from the Expert Panels in relation to the safety and performance of any device. The Expert Panels are appointed by the Commission of the EU for a renewable term of three years or may be included on a central list of available experts from which they may be called to support panels. The list of experts and their views are publicly available on the EU Commission website.

 

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