The European Commission has continued to work on guidance for manufacturers and other economic operators of medical devices and personal protective equipment (PPE) to provide answers on specific questions that arouse in the course of the current crisis. Furthermore, certain European countries have started to publish exemptions and specifications for COVID-19 relevant products.
The situation is highly dynamic – it is thus very important to have an eye on the most recent developments. Supplementary to our last article, “European Recommendation on Regulatory Exemptions for COVID-19 Products”.
Guidance for medical devices and PPE published in Europe related to COVID-19
We would advise to look at the following guidance if relevant for you:
- The Commission has launched a website answering questions about regulatory requirements and conformity assessment procedures of Personal Protective Equipment (PPE), e.g. face masks. This should help manufacturers to evaluate the requirements to place PPE on the European markets in the current situation. Please let us know should you require the corresponding guidance document.
- Similarly, the Commission has published a guidance document to answer questions about regulatory requirements and conformity assessment procedures of medical devices falling under the MDD, AIMDD or IVDD. This should help manufacturers to evaluate the requirements to place medical devices on the European markets in the current situation. Please let us know should you require the corresponding guidance document.
- The Medical Device Coordination Group (MDCG) issued document MDCG 2020-4. This document takes into consideration Notified Body audits in times of quarantine orders and travel restrictions: “This document has been developed to outline temporary extraordinary measures for notified bodies to follow in this interim period in order to allow continued availability of safe medical devices to the market and assist in the prevention of the risk of medical device shortages.” The MDCG says that the document is applicable for the MDD, AIMDD and IVDD, but may also be extended to the MDR and IVDR. Please let us know should you require the corresponding guidance document.
- The Commission has provided a list of standards issued by the IMDRF summarizing the applicability of standards in different regulatory regions. It has recently been adapted to the changed requirements in the current COVID-19 crisis. Please let us know should you require the corresponding list.
National considerations on COVID-19 related temporarily changes
As mentioned in our previous article, the European Commission has recommended to member states to make use of exemptions for products that are urgently needed in the current crisis. All economic operators should carefully monitor the local requirements in the local counties of sales.
The German Federal Institute for Drugs and Medical Devices (BfArM) has published several notes on face masks in the context of the COVID-19 pandemic. One article includes a decision flow chart to determine how masks falling either under the MDD or PPE Regulation will be regulated in the current situation. Please refer also to the exemptions we have mentioned in our previous article. Another article clarifies the different types of masks and how these are regulated in Germany.
Up to now, the articles are available only in German. Please let us know should you require additional information.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has been busy and published several documents as well.
In addition to the specifications for a simplified market access for ventilators and ventilator components, the agency published a similar guidance document for rapidly manufactured CPAP systems.
Finally, the MHRA has added useful guidance for IVD tests and test kits intended for the diagnosis of the Corona virus. It includes specifications for certain self-tests or point-of-care tests, which may give a good indication of what is generally required in the EU these types of tests.
In this context, the UK also requires manufacturers outside the UK to register their IVD test kits with a separate registration form.
Sources: Websites of the European Commission, BfArM and MHRA