May 13, 2020

Our coverage of regulatory responses to the COVID-19 pandemic has featured the European Union, as well as the United Kingdom as it transitions to a new status outside the organization. But what of the rest of Europe? Here we look at measures introduced by three of the four European Free Trade Association (EFTA) countries, along with developments in Russia.

Norway breaks ground among EFTA nations

In late March Norway signed a Joint Procurement Agreement (JPA) with the European Commission (EC) that aims to secure access to specific medical countermeasures and ensure availability of necessary equipment in times of serious cross-border health threats. The JPA will support Norway’s import-dependent supply chain in securing the supply of medicines, medical devices, and protective equipment needed to combat the COVID-19 pandemic.

Following a dialogue between the Norwegian Ministry of Foreign Affairs and the EC regarding the restrictions for exports of personal protective equipment (PPE) outside the EU, the EC decided to exclude the four EFTA states from the scope of the Implementing Regulation No. 2020/402, as it was not its intention to place restrictions on EFTA countries. However, exported equipment from the EU will not be re-exported from Norway to other countries outside the EU.

The Norwegian Medicines Agency (NOMA) has updated its information on the approval, manufacture, and import of disinfectants in Norway. The regulation of disinfectants will depend on its intended use and the claims used in product marketing. Notably, disinfectants which act as accessories to a medical device must likewise be CE marked and may not be marketed for general use on other medical equipment.

NOMA announced that most of their staff will be working from home while the pandemic poses a serious threat. Response time is within normal expectations for most cases, although priority will be given to issues of high urgency or impact to health.

Another announcement from NOMA stipulated that interested suppliers of medical devices and infection control equipment related to the COVID-19 pandemic must contact the Hospital Procurement Agency (Sykehusinnkjøp) by email. Their FAQ page about COVID-19 also provides information.

NOMA also publishedguideline describing the applicable regulations for marketing protective equipment (e.g., face masks, gloves) used against the COVID-19 pandemic. Protective equipment must be CE marked and may either be regulated as a medical device or personal protective equipment (PPE), depending on the intended use and the manufacturer’s claims. Specific requirements for importation and distribution of these products are also provided.

A new guidance document from NOMA details relevant regulatory information about rapid testing and self-testing equipment. Rapid or “point-of-care” tests are to be used by healthcare professionals only. Rapid tests are considered general IVD equipment, and in some cases the manufacturer can self-declare conformity to relevant regulations and place the CE mark on its own. Self-testing equipment, on the other hand, must be assessed by a Notified Body and CE marked with the four-digit code of the NB. The guidance also includes information for importation and distribution.

Finally, NOMA announced temporary exemptions for IVDs that are manufactured by health institutions or “self-made”. The exemptions include the movement of the self-made IVDs between health institutions, as well as the analysis of samples on a case-to-case basis (e.g., from one institution to another). Self-made IVDs do not require CE marking, but health institutions should be able to provide technical documentation upon request.

Iceland announces access limitations and export requirement

The Icelandic Medicines Agency (IMA) announced shorter calling hours starting March 24. Telephone calls will only be entertained from 10 am to 12 pm and from 1 pm to 3 pm. This arrangement will last until further notice from the Agency. Stakeholders may opt to send requests via the Agency’s main e-mail address, which is continuously monitored between 8 am and 4 pm. However, coronavirus-related matters will be prioritized. The reception desk at the IMA headquarters will remain closed.

The IMA also announced that approval from the Agency is required for the export of protective clothing for healthcare professionals in accordance with Rule No. 301/2020 of the Ministry of Health. The Rule is valid as of April 25.

Learn how other device markets are responding to COVID-19.

Switzerland expedites approvals and cracks down on non-compliant masks

Swissmedic, the regulatory body governing medical devices in the country, published an information sheet which provides answers to the increasing number of regulatory questions from economic operators regarding the placing of protective masks, gloves, hand sanitizers, and COVID-19 tests on the Swiss market.

An announcement from Swissmedic addresses the placement of essential ventilators on the market, promising swift and pragmatic decisions on exemptions made for non-compliant medical devices used in life-threatening situations, considering the exceptional circumstances resulting from COVID-19. The application must include information and documentation on device safety and a benefit-risk analysis.

In accordance with the Ordinance on Measures to Combat the Coronavirus (COVID-19), Swissmedic has updated their information on exemptions for market authorizations, which initially applied to ventilators only, to include other essential medical devices listed in Annex 4 of the Ordinance (monitoring equipment for intensive care, IVD tests, surgical masks, surgical gloves, medical oxygen, and infusion solutions) which have not undergone or completed the required conformity assessment following a risk assessment.

Swissmedic published a warning about non-compliant medical face masks increasingly being offered in Switzerland. Medical face masks, surgical masks, or hygiene masks in compliance with EN 14683 are considered medical devices and must therefore be CE marked accordingly. The announcement clarifies that exceptions for non-compliant face masks described in Art. 4n of the COVID-19 Ordinance 2 only apply to non-medical use masks. Non-compliant masks must not be used in hospitals or medical practices by persons in direct contact with patients.

Most recently, Swissmedic announced that the enforcement of the revised Swiss medical device legislations—the modified Therapeutic Products Act (TPA) and Human Research Act (HRA)—will be deferred by one year (to May 26, 2021) as part of its alignment with the application of the EU medical device legislation.

Russia changes access protocols and publishes new Regulations

Russia’s Federal Service for Surveillance in Healthcare (Roszdravnadzor) announced that all access to official buildings will only be allowed to government personnel. All submissions and dossiers are to be submitted either electronically, by mail, or dropped into the building's physical mailbox.

Roszdravnadzor announced that all consultations on the registration of IVDs for the diagnosis of COVID-19 will be free of charge as of March 20. The Russian Ministry of Health has also published a general COVID-19 information website.

The Russian government published Resolution No. 233/2020, implementing a temporary ban on the exportation of 16 types of listed medical devices including face/surgical masks, respirators, protective glasses and clothes, etc. This ban will remain in place until June 1. 

Also published was Resolution No. 299/2020, which simplifies the registration route for 36 types of low-risk protective medical devices, including surgical/protective face masks, respirators, medical protective clothes, surgical suits, medical gloves, etc. According to the Resolution, Roszdravnadzor will make approval decisions for these devices within five days from receipt. An additional guidance document was released with further details. ​

The Russian Ministry of Health announced the expedited processing of registrations for IVDs intended to be used for COVID-19 diagnosis. This initiative was formalized and expanded in Resolution No. 430/2020, introducing a six-day approval process for batches of medical devices and IVDs to be used in the prevention and treatment of COVID-19. The Resolution allows for non-registered medical devices and IVDs included in the annexed list to be imported without further registration and until the end of 2020. ​

Resources for device registration in non-EU European countries:

Author

  • Timothy Herr

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