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...

1. European Emergency Use Routes
for COVID-19
By: Nikita Angane, MS
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.

2. Page 2 of 2
Have questions about marketing your medical device? Call us today at 248-987-4497 or
email us at info@emmainternational.com.
1 EU Commission (March 2020) on conformity assessmentand market surveillanceprocedures 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
2 European 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