Chubb Life Science - Medical Device Regulation
Published on 28/05/2021
On 26th May 2021, the new Medical Device Regulation (MDR) will be implemented in the European Economic Area as the legal basis for the manufacture of medical devices.
In this report, Chubb examines the changes the new regulation will bring, the obligations of non-EU medical device manufacturers and how BREXIT affects them.
The new Medical Device Regulation (MDR) will come into force on May 26 2021
In 2017, the EU adopted new Medical Device Regulation (MDR) EU 2017/745 to make the introduction of medical devices into the EU market safer. After a transition period of 3 years, the regulation should be fully in force. The outbreak of the COVID-19 pandemic necessitated a delay of one year. But now the time has come. On May 26 2021, the MDR will apply in the European Economic Area as the legal basis for medical device manufacturing.
Obligations for medical device manufacturers with non-EU residence
Authorised Representative: Manufacturers with a registered office outside the European Union already had to appoint an authorised representative in the EU according to the Medical Directive 93/42/EEC, Article 14.
The role of the Authorised Representative is continued in the MDR (EU) 2017/745 in Article 11 and is attended to with detailed tasks. From an insurance perspective, these extended tasks lead to complicated and unsatisfactory solutions, which make the security desired by the legislator extremely difficult.
Authorised Representative shall have a person at their site who has to have an academic or comparable education in law, medicine, pharmacy, engineering or another relevant scientific discipline. In doing so, the legislature wants to ensure that the Authorised Representative has expertise available to handle the various new responsibilities.
How BREXIT affects medical devices
The latest MDR legislation in Europe and regulatory reform by the FDA have left many companies unsure about how to pursue the best regulatory pathway.
Chubb’s UK branch can continue to provide a policy solution that will provide continuous and uninterrupted service whilst maintaining S&P AA rating.
Chubb will be authorised by the PRA while also remaining part of the same legal entity Chubb European Group SE. This will allow UK underwriters to underwrite risks located in the EU on the basis that they are underwriting on behalf of Chubb European Group SE, an insurer authorised in the EU.
Chubb Underwriters in the EU will also be able to underwrite risks located in the UK on the basis that Chubb European Group SE has an authorised branch in the UK
Click here to read the full report: https://www.chubb.com/content/dam/chubb-sites/chubb-com/uk-en/hosted_documents/8747d_-_UK7977-MD_04_21_-_Chubb_Life_Science_-_medical_device_regulation%20(1).pdf