Overview:

United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) developed a list of medical devices which can be marketed without CE marking.

MHRA plans to reduce the procedures for manufacturers in order to fulfill the need of medical devices to consumers during public health emergencies. This includes a list of 50 devices and device families to be accessible to the UK citizens.

Exempted Medical Devices

The conditions of exemptions are:

  1. If the device is a custom-made device. Custom-made devices are supplied directly to the patients/user by the manufacturer without free movement of the device in the EU market.
  2. If the device is an investigational device. Every investigational device should have a CE marking except for the device posing lowest risk to the EU citizen.
  3. If the device is derogated. This means, the device is not certified but there is a public health risk if the device is not made available.

MDR Article 59

EU MDR added a new regulation in the Medical Device Regulation (EU) 2020/561 amending article 59. This states that EU member states can exempt CE marking and allows European Commission to expand the exemption of a device if it has been exempted in one-member state. As per the European lawmakers this will aid in fast responses in situations like COVID-19. Article 59 of EU MDR 2020/561 has been implemented from April 24, 2020.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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