1. Medical Devices Regulation
On 9 November, Lars Patrick Berg (ECR, Germany) tabled a question on the medical devices’ regulation. The MEP asked what resources the Commission is providing to affected manufacturers and authorized bodies to cover the rising costs, how, in the Commission’s opinion, should the downward trend in healthcare for EU citizens, and in particular smaller patient populations, be compensated for, and what measures does the Commission envisage to ensure that existing products that have proved to be safe and efficient are not subject to unnecessary additional certification.
On 12 January, Commissioner Kyriakides responded that the Commission recognizes that the use of MDR is a challenging task for the entire sector, which can lead to the extra costs involved with device certification. Ms. Kyriakides also remarked that according to Article 120 of the MDR, during a transition period until May 2024 devices that follow the previous Directives 90/385/EEC or 93/42/EEC may be placed on the market, under certain conditions to minimize the burden and cost of devices lawfully marketed under such regulations, the MDR exempts them from the obligation to make clinical inquiries if their clinical assessment is supported by sufficient clinical data. She also highlighted that the Commission provides descriptive information to all interested parties, including specific newsletters and publications, and supports the development of MDCG guidance documents. In addition, the EU4Health program provides funding to improve health in the EU, including the availability and affordability of medical devices.
2. Use of medicines to treat COVID-19 and the risk of antimicrobial resistance
On 9 November, Joanna Kopcińska (ECR, Poland) tabled a question on the use of medicines to treat COVID-19 and the risk of antimicrobial resistance. The MEP asked, if the Commission will carry out assessments of how the use of medicines to treat COVID-19 impacts the development of antimicrobial resistance.
On 17 January, Ms. Kyriakides responded to this question that tackling antimicrobial resistance (AMR) is a high priority for the Commission. The COVID-19 pandemic stressed the need of having effective antimicrobials that must be used prudently. The Commission does not currently plan to evaluate how the use of drugs to treat coronavirus affects the development of AMR. She remarked how the European Centre for Disease Prevention and Control (ECDC) published its Annual Epidemiological Report on the antimicrobial consumption in the EU the report notes that despite the pandemic, most countries in the EU and the European Economic Area recorded a significant reduction in the consumption of antibacterials between 2019 and 2020 in both public areas and hospitals. In addition, she added that, the European Medicines Agency recently published an article on the coronavirus and its impact on AMR. Ms. Kyriakides remarked that alliance agencies routinely continue to monitor antibiotics given to coronavirus patients to optimize patient outcomes, minimize the risk of side effects, and assess long-term consequences such as increased AMR. She also highlighted that the Commission supports the use of evidence-based guidelines that promote the appropriate use of antibiotics for the treatment of coronavirus.
3. Carcinogenic substance in lateral flow test swabs
On 8 December, Ioannis Lagos(NI, Greece) tabled a question on the carcinogenic substance in lateral flow test swabs now that they have become mandatory and that after being tested in a laboratory in Cyprus a presence of a prohibited substance was detected. Lagos asked how the Commission intended to tackle this issue, since, according to the manufacturer this medical device has been tested for compliance with European legislation (Medical Device Regulation (EU) 2017/745).
On 14 February, Ms. Kyriakides answered that The European Chemicals Agency (ECHA) does not list ethylene oxide (EO) as a "prohibited substance" but explains the various uses of the substance "by buyers, in articles, by experts (widespread use), in formulating or repackaging, in industrial sites and in production". She remarked that swabs used in lateral flow tests can be sterilized with ethylene oxide. The manufacturer is responsible for ensuring compliance with the relevant EU legislation (Regulation (EU) 2017/745 on medical devices, which replaces Directive 93/42/EEC of 26 May 2021) regarding stability requirements and applicable performance, including allowable residual EO parameters in selected EO-sterilized medical devices.