medicaldeviceslegal Medical devices legal and regulatory blog About Erik VollebregtTag browsing: Brexit The Blue Guide 2022 update – new elements regarding applicability of EU law on productsMDR date of application next month – and the book...
Medical Devices Act of 2021 was passed to address the regulatory gap for medical devices created when the UK officially left the European Union (EU) in January 2021. Until then, medical devices were required to meet EU regulatory requirements, including the EU’s Medical Device Regulation (MDR)...
We knew that this proposal was coming, because the Commission had announced in its White Paper on AI that EU product legislation would be impacted, and mentioned medical devices regulation specifically in that context: “The proposal sets harmonised rules for the development, placement on the market...
On 26 May 2021, Regulation (EU) 2017/745 on medical devices (the “EU MDR”) took effect in the EU. The EU MDR introduced substantial changes to the regulatory framework in response to revolutionary technological development in digital health, artificial intelligence, including...
Regulation to the implementation of the Falsified Medicines Directive, and the evolution of the Medical Devices Regulation (MDR) or the current uncertainty around Brexit in Europe, change is everywhere. With so many new developments in progress, it is almost impossible to keep track of all the ...
Stay up to date with the latest brexit news from BSI Medical Devices, with two notified bodys in the UK and NL both full scope designations to MDR and IVDR.
Going forward, the scope of BSI UK’s new MDR designation ranges from medical devices incorporating medicinal substances or nanomaterial to class III custom-made implantable devices. However, the future implications of NB designations and/or qualifications need to be watched closely, as post-BREXIT ...
ISO 13485 certificates issued under the UKAS accreditation do not need to be transferred to an EU-27 conformity assessment body. UKAS' membership of the International Accreditation Forum (IAF) will continue unaffected by Brexit. UKAS will continue to be a member of the European co-operation for...
Read now our Brexit: Medical Devices Newsflash from March 2019 and learn more about the latest regulatory updates.
The first is a decision by the UK to offer a hefty transition period for companies to adjust to any new regulations, with devices that have an EU “CE” mark recognised as safe for the UK market for up to five years. So while the UK is not giving up on its post-Brexit equivalent,...