Medical Devices Exempt from the CE mark

by Nikita Angane | Aug 14, 2020 | FDA, Medical Devices, Quality, Regulatory

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is taking big steps to deal with the pandemic during the ongoing 11 months transition period granted for its hard exit from the EU. As part of its preparation, UK’s MHRA released a list of over 50 medical devices and device families that are exempted from requiring a CE mark to be sold in the UK. The exemption is issued to the manufacturer of the medical device and may not apply to sales via a distributor. This list can be used by the British healthcare providers and the citizens to determine which devices that do not bear a CE mark are still safe for use.1

This exemption list from the MHRA is definitely intended to help the supply shortages during the pandemic as well as during any shortages faced post-Brexit. The MHRA is still accepting applications from manufacturers to grant such exemptions and has stated that the approval of such exemptions will depend on the need and supply availability of a CE marked device.²

The EU also did something similar in April 2020 when the pandemic was at its peak in Europe. The EU Commission released Regulation 2020/561 on April 23, 2020 which delayed the EU MDR implementation date for a year and amended certain clauses of the MDR. Amendment to article 59 of the EU MDR allows for the sale and distribution of medical devices that are essential for public health without a CE mark ahead of the EU MDR implementation date. However, this decision is solely left on the member states to exempt devices requiring a CE mark to be used in their territory. A member state that has put into effect such exemptions may inform other member states and the EU Commission that will allow the use of the device on a larger scale. This amendment also allows for the EU Commission to expand the use of devices not bearing a CE mark to other member states in order to help the supply shortages during the pandemic.³In all other cases, Article 1 of the EU MDD states that a medical device can be exempted from a CE mark only in the following circumstances:

The device is a custom-made device
The device is intended for clinical investigations.

Do you want to know how this exemption may apply to your medical device? Give us a call today at 248-987-4497 or email us at info@emmainternational.com.

¹Eergo (Aug 2020) UK MHRA publishes list of exempted medical devices retrieved on 08/05/2020 from https://www.emergobyul.com/blog/2020/07/uk-mhra-publishes-list-exempted-medical-devices

²UK MHRA (August 2020) Medical devices given exceptional use authorizations during the COVID-19 pandemic retrieved on 08/06/2020 from https://www.gov.uk/government/publications/medical-devices-given-exceptional-use-authorisations-during-the-covid-19-pandemic

³EU Commission (April 2020) REGULATION (EU) 2020/561 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions retrieved on 08/05/2020 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32020R0561&from=EN

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.