Regulatory Focus™ > News Articles > 2021 > 6 > Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

Posted 03 June 2021 | By Nick Paul Taylor 

Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

3014 Switzerland has adopted supplemental provisions to its new Medical Devices Ordinance (MedDO) to soften the impact of its split from the European Union. The action comes as the failure to update a mutual recognition agreement (MRA) erects barriers to trade between Switzerland and the EU.
Swiss medical device manufacturers have enjoyed barrier-free access to the EU single market since 2001. However, the EU refused to consider updating the MRA in light of the new EU Medical Device Regulation until there is a deal on a proposed Institutional Framework Agreement with Switzerland. The failure to reach an agreement on the framework means the MRA remains unchanged.
Switzerland responded to the loss of barrier-free access to the single market and resources such as the EUDAMED database by amending MedDO. The amendment unilaterally allows devices certified in the EU to continue entering Switzerland to avoid supply disruptions. Switzerland has also added requirements for the registration of economic operators, the reporting of serious incidents and the establishment of authorized representatives for manufacturers based outside the country.
The European Commission set out its side of the argument in a separate statement, explaining that the EU offered a transitional validity period for existing devices with Swiss certificates until 26 May 2024. However, the two sides failed to reach an agreement in time. The Commission said the failure happened despite “consistent efforts and EU readiness to conclude such a transitional arrangement.”
EU officials “do not expect large disruptions in the health sector during the COVID-19 pandemic” but the long-term consequences to the Swiss industry could be significant. The Swiss Medical Technology Association said its members will pay an estimated CHF 114 million ($127 million) to meet the administrative requirements associated with Switzerland becoming a third country and pay a further CHF 75 million per year in ongoing additional costs.
Beat Vonlanthen, president of Swiss Medtech, said the costs are “manageable” but warned of the broader consequences of being cut off from the single market. “We are more concerned about the loss of market attractiveness and the associated negative consequences in the future,” Vonlanthen said. “Anyone who simply states that the administrative costs are bearable is completely ignoring how tough the international competition is.”
Swissmedic Notice, Commission Notice, Press Release
EMA taskforce finds insufficient evidence on inhaled corticosteroids in COVID-19
The European Medicines Agency’s (EMA) COVID-19 taskforce has found there is a lack of evidence to support the use of inhaled corticosteroids in patients infected with the pandemic coronavirus.
EMA’s taskforce initiated the review of the current evidence in response to growing interest in the use of inhaled corticosteroids such as budesonide and ciclesonide to treat COVID-19 outpatients. The interest is underpinned by evidence of the positive effect of systemic corticosteroid dexamethasone on hospitalized COVID-19 patients and a series of recent clinical trial readouts on inhaled products.
Having analyzed the readouts, the taskforce concluded that more evidence from clinical trials is needed to show the benefits of inhaled corticosteroids in the patient population. The taskforce saw no safety risks in the current evidence, but is unable to rule out the potential for inhaled corticosteroids to harm COVID-19 patients who have normal oxygen levels.
EMA convened experts from across the European medicines regulatory network for the taskforce to enable fast, coordinated regulatory actions on COVID-19 treatments and vaccines.
EMA Notice
Finland ties size of drug shortage notification fee to timeliness of submission
The Finnish Medicines Agency (Fimea) has adopted a fee schedule that will see companies that fail to submit shortage notifications on time pay more. Fimea’s shortage notification fees range from €70 ($85) to €1,000 depending on how much warning about the supply disruption the company provides.
Under the terms of the Finnish Medicines Act, marketing authorization holders need to tell Fimea of temporary and permanent suspensions to the supply of products at least two months in advance. If a company complies with that requirement, Fimea will charge €70 for processing the notification. The failure to meet the requirement incurs larger fees.
The highest fee, €1,000, is reserved for companies that give Fimea less than two weeks’ notice of the suspension of sales. Companies that give Fimea between two months and two weeks’ notice will pay €200.
Fimea introduced the tiered fee structure in response to the widespread failure of companies to give the two months’ notice mandated by the Finnish Medicines Act. Last year, 3% of medicine shortage notifications were submitted at least two months before the anticipated supply disruption. Fimea wants to increase the rate of timely submissions to boost its chances of averting drug shortages.
The new fee schedule, which replaces a document from 2019, also features changes to what Fimea charges for applications related to medical devices. Fimea made the changes in light of the terms of the new rules on medical devices. Finally, restrictions imposed in relation to COVID-19 led Fimea to establish a fee for remote inspections, which is less than the fee for in-person visits.
Fimea Notice
EDQM seeks feedback on cell-based potency assay for TNF-alpha antagonists
The European Directorate for the Quality of Medicines (EDQM) is seeking feedback on a new general chapter on cell-based assays for the determination of the potency of TNF-alpha antagonists.
Multiple TNF-alpha antagonists such as AbbVie’s Humira and Amgen’s Enbrel are now on the market and, in some cases, facing competition from biosimilars. EDQM said the growth of the sector “has led to an increased variety of approaches to bioassay selection for assessing and comparing potencies of anti-TNF-alpha biologics and their biosimilars” and to questions about the most appropriate tests.
The European Pharmacopoeia has responded to the changes in the TNF-alpha antagonist market with a new general chapter that describes the execution of four specific cell-based assay procedures. Other sections of the chapter address data analysis, system suitability, assay acceptance criteria and results evaluation.
EDQM is strongly encouraging companies affected by the draft to perform their own experimental verifications and submit feedback that could shape the chapter and ensure it remains state of the art. The deadline for comments is 30 June.
The draft chapter is the first of three planned “horizontal standards” for monoclonal antibodies.
EDQM Notice
Denmark shares guidance on marketing professional-use IVDs to laypeople
The Danish Medicines Agency (DKMA) has explained when and how COVID-19 in vitro diagnostics (IVDs) cleared for use by professionals can be marketed for self-use by laypeople.
European legislation places additional essential requirements on IVDs intended for use by laypeople. IVDs that receive CE marks certifying them for use by professionals do not need to meet those extra requirements but, as a consequence, are unable to be routinely marketed to laypeople. Interest in COVID-19 self-testing has led to an increase in questions to DKMA about the rules.
DKMA responded with a public statement that explains an IVD manufacturer or its EU representative can apply to place a device that is not CE marked for use in laypeople on the Danish market. Neither importers nor distributors can make the request.
Only certain devices are eligible for use without being CE marked in laypeople. DKMA will consider permitting the use of IVDs if the manufacturer has sufficient evidence on the use of an IVD by laypeople. In practice, the requirement means only manufacturers that have already filed with a notified body for a CE mark in laypeople are eligible for the regulatory flexibility.
DKMA Guidance


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