In Europe, medical devices are regulated under the Directive 93/42/EEC—the “Medical Devices Directive” (MDD) which is annulled by the Medical Devices Regulation (MDR) (EU) No. 2017/745, whereas Personal Protective Equipment is regulated under Regulation (EU) 2016/425 (the PPE regulation), which covers the design, manufacture, and marketing of personal protective equipment.
Under normal circumstances, devices would require a notified body involvement or self-declaration of conformity depending on the risk classification of the product. In light of the pandemic and the urgency of the situation, the European Commission has allowed for medical devices and PPEs to be distributed in the EU that do not bear a CE mark and have allowed for member states to do the same.
European Commission has allowed the distribution of PPEs and medical devices that do not bear a CE mark only if the following conditions are met:1
- PPEs are manufactured in accordance with the technical solutions outlined in Article 14 of Regulation (EU) 2016/425 or in accordance with the recommendations from the World Health Organization.
- The Product must meet the applicable essential health and safety requirements.
- Where non-CE marked PPE is intended to enter the EU market, the relevant market surveillance authorities evaluate the products and, if they are found to be compliant with the essential health and safety requirements laid down by the relevant regulation, they are placed on the market only for a limited period.
The EU commission has asked notified bodies to prioritize the conformity assessments of PPEs that are necessary for protection during the outbreak and the member states market surveillance authorities to focus on non-compliant PPEs or medical devices.1
The EU Commission has implemented the ‘Green lanes’ initiative, under the guidelines for border management, which recommends that all internal EU borders should stay open to allow for a free flow of essential medical supplies as well as essential medical professionals.2
We are continuously monitoring the changing regulatory landscape and we will keep you updated on the impact it has on the medical device industry.
Have questions about marketing your medical device? Call us today at 248-987-4497 or email us at firstname.lastname@example.org.
1EU Commission (March 2020) on conformity assessment and market surveillance procedures within the context of the COVID-19 Threat retrieved on 04/29/2020 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020H0403&from=EN
2European Commission (March 2020) on the implementation of the Green Lanes under the Guidelines for border management measures to protect health and ensure the availability of goods and essential services retrieved on 04/29/2020 from https://ec.europa.eu/transport/sites/transport/files/legislation/2020-03-23-communication-green-lanes_en.pdf