United Kingdom has left the EU and the transition period after Brexit comes to an end this year. This means from 1stJanuary 2021, there is a new regulatory landscape being rolled out for medical devices and IVD devices in the UK. The amendments are still in a draft phase and the signals from Medicines and Healthcare products Regulatory Agency (MHRA) indicate it is very likely that the changes remain even in the event of a Brexit deal between the UK and the EU.
These changes will have both short and long term impact on many things such as registration, conformity assessment, and marking of devices.
One of the new requirements is that a non-UK based manufacturer need to appoint a UK Responsible Person (UKRP) resident in the UK to be able to place medical devices and IVD on the UK market. This is required for both new and currently placed devices and mandatory from 1st January 2021.
A UKRP is essentially the same as an authorized representative established in the UK, with the role to act and carry out tasks in relation to the manufacturer’s obligations. For instance, registration of the manufacturer’s devices and any changes with the MHRA. UKRP shall review and keep the Technical Documentation and Declaration of Conformity readily available and act on behalf of the manufacturer in communication with MHRA.
We always advise a manufacturer to consider whether the requirement for a UKRP to review and keep available the complete product technical documentation is appropriate for the distributer or importer. It may be beneficial to appoint an independent professional UKRP, as it provides separation of regulatory aspects from supply chain aspects.
QAdvis has 10 years of experience of supporting international companies as their Authorized Representative in the EU. We are also happy that we now offer our services to be your UKRP from our QAdvis UK Ltd. office in Edinburgh.
Just get in touch with us, we are delighted to support you with a successful post-Brexit clearance.
After the temporary halt in June 2020, the process of harmonizing standards with MDR and IVDR has taken a promising step forward. The EU Commission standardization request that was rejected by CEN/CENELEC has been revised and a new draft standardization request was released for stakeholder review in late October.
It is the EU Commission’s objective to have a final version adopted in the first quarter of 2021 for the acceptance by CEN/CENELEC. Once accepted it will provide the legal ground for the Commission to be able to publish standards harmonized with MDR and IVDR in the Official Journal of the European Union.
The latest draft includes for example: EN ISO 14971:2019, EN 62304:2006+A1:2015, EN ISO 13485:2016 but also the new cybersecurity related standards IEC 80001-5-1 and IEC TR 60601-4-5.
In total, it includes approximately 200 existing standards and 30 new standards. All standards are listed with a deadline for adoption by 27 May 2024. If all goes well, we may even see the first publications in late spring 2021.
For many of us, the past year has not turned out the way as it was expected. With several rescheduled meetings and events, work from home, online training sessions and remote audits it has been a challenging 2020. We have slowly adapted to this new reality and are finding alternatives to the classic way or working, improving our skills in remote communication for each day.
With that said we are looking forward to starting 2021 with new energy and planning for a busy and eventful, but also interesting year that we have great expectations for.
With the regulatory landscape changing, Notified Bodies being designated, guidelines developed and published, standards revised and less than six months to the date of application for MDR, QAdvis have strengthen our team in several areas and look forward to the year of 2021.
Merry Christmas, and we all hope for a really happy new year!
If you have any questions about our newsletter, please feel free to contact Hermine Redl, Office Manager, by phone on +46 8 621 01 05 or email here.
We are very glad to welcome two new consultants to our team. Irene Sebastianutto PhD, native Italian, is based in our Lund office and Patricia Marmol PhD, native Spanish, is based in Stockholm. With these new fantastic colleagues, we are strengthening our clinical team and further increasing our international platform. Read more about our clinical services here.
Patricia is very experienced in molecular biology and biochemistry, both in vivo and in vitro. She has a background in academic research, which includes almost ten years of experience as a researcher at Karolinska Institute in type 2 diabetes, metabolism and biomarker and metabolite analysis. Her qualification also includes postgraduate education in regulatory affairs and clinical trials. Patricia uses a rational and fact-based approach and seeks for quality in her commitments.
Irene has her academic merits in biomedicine and neuroscience from Lund University and has over ten years of experience in preclinical research within the field of neurodegenerative disorders. During the past year, she has focused on medical devices and in particular clinical evaluation reports. Irene has a broad interest for life sciences, an analytical mind, and a genuine passion for innovation.
QAdvis Academy provides open courses and seminars as well as company-adapted training courses and workshops. All our courses can be customized to your own company-adapted training course. Read more about it here …
We also continue our cooperation on courses and seminars with both Swedish Medtech and Intertek Academy.