The COVID-19 pandemic is having a significant impact on the medical device industry. For instance, so-called 'notified bodies' (ie, organisations that have been designated by an EU member state to assess the conformity of certain products with the applicable essential technical requirements before they are placed on the EU market) have already closed or restricted their activities, and there are no longer on-site audits. Authorities have been affected similarly. Companies and production sites must adapt due to the pandemic. Suppliers are shutting down production or are unable to manufacture enough products to meet the high demands.
The COVID-19 pandemic has also affected preparations for the upcoming EU Medical Device Regulation (2017/745) (MDR). Scientists and engineers who have been working on the new MDR framework for several years are now switching to COVID-19-related research, while research and combat teams and research institutions and industry are building up additional research and production capacities to meet the increasing demands due to COVID-19.
On 25 March 2020 the European Commission announced that it intends to postpone the MDR application date for one year from May 2020 to May 2021. The decision was reached with patient health and safety as a guiding principle.
This decision at least relieves the pressure on national authorities, including notified bodies, manufacturers and other actors, as it allows them to focus on urgent priorities relating to fighting the COVID-19 pandemic.
Further, new questions have arisen: will there be transition periods, what are the implications on local implementing acts and do manufacturers have to adhere to the Medical Device Coordination Group guidelines?
On 3 April 2020 the European Commission published a proposal to postpone the application for the MDR to 26 May 2021. The European Commission submitted this proposal in order to allow the European Parliament and the European Council to adopt it quickly, as the current date of application is 26 May 2020.
In Vitro Diagnostic Regulation
Unlike the MDR proposal, there is – so far – no similar decision for the EU In Vitro Diagnostic Regulation (2017/746). Although this regulation has a longer implementation time, diagnostic manufacturers and authorities must prepare for major changes and requirements to adapt to the new framework. Their current capacity is also focused on the task of keeping critical diagnostic tests available, despite the challenges that COVID-19 is creating for both production and distribution.
The industry has highly welcomed the decision to postpone the MDR and requests a similar approach for the In Vitro Diagnostic Regulation.
CE marking
COVID-19 has significantly increased the demand for protective equipment such as face shields, protective mouth and nose masks, protective clothing and gloves.
Such products qualify as 'protective personal equipment' (PPE) or medical devices, depending on their purpose. However, placing them on the EU market generally requires a lengthy conformity assessment procedure and obtaining a CE marking that demonstrates conformity with regulations based on the positive results from such procedure.
In order to adapt the availability of protective products, whether medical devices or PPE, as quickly as possible to the increasing demand, the European Commission has simplified their market access with its EU Recommendation 2020/403 of 13 March 2020. The recommendation sets out that competent market surveillance authorities and notified bodies must take all measures available to ensure that healthcare professionals receive equipment with a high level of protection for the duration of the COVID-19 pandemic.
For instance, according to the German Federal Ministries of Labour and Social Affairs and Health, PPE and medical devices may be placed on the market without CE marking temporarily and in individual cases.
Medical device companies must consider and discuss with their competent authorities and notified bodies whether their products may benefit from the market access simplification measures. In addition, manufacturers should ensure that the use of the equipment is understood by its users and provide manuals or train users on the equipment so that they are used safely.
European Standards and other technical documents available for free
In line with the above measures and on request by the European Commission, the European Standardisation Organisations – namely, the European Committee for Standardisation and the European Committee for Electrotechnical Standardisation – with support from all members, decided to make a number of EU standards and technical documents for medical devices and PPE available free of charge until further notice in order to support the fight against the COVID-19. This will help companies wanting to switch product lines to manufacture urgently needed equipment at short notice. EU standards describe essential requirements for masks, medical gloves and protective clothing. Interested companies and organisations can download the standards online.
Export requires authorisation
In order to meet the high demand for PPE and protective medical devices in the European Union, the European Commission has, by its EU Regulation 2020/402 of 14 March 2020, temporarily made the export of certain products subject to authorisation.
An export authorisation is granted only in individual cases. These newly introduced export restrictions are difficult for companies that are contracted to supply products covered by this regulation to third countries. Exports of medical protective equipment from the European Union to European Free Trade Association states (ie, Switzerland, Liechtenstein, Norway and Iceland) are exempted from the export authorisation requirement.
Companies should consider applying for such an export licence and, if not, what legal or commercial possibilities exist to deal with the export ban and existing business relations with their partners.
