What should you know on UKCA extension
Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Importer), then the UKCA requirements, then the new legislation consultation (which will largely harmonise UK law with the MDR and IVDR) and now the extension of the unilateral recognition of CE Marks to allow manufacturers more time to obtain a UKCA marks.
But what all this means for medical devices manufacturers that are already selling in the UK or that plan to sell to the UK. We will review that with Alex Denoon, partner at Bristows.
Don’t forget to check the links below for more details.
Who is Alex Denoon?
Alex advises about Life Sciences regulatory issues all day every day and has been doing so for 30 years.
He enjoys working with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals, medical devices and IVDs. Alex has been involved in the development of a number of regulatory frameworks and guidelines. Legal 500 describes Alex as “a straight-talking, commercially astute technology specialist who is always willing to take a view” and who delivers “out-of-the-box solutions”.
Who is Monir El Azzouzi?
Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.
Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.
- Alex Denoon Linkedin : https://www.linkedin.com/in/alexdenoon
- Bristows law firm linkedin page: https://www.linkedin.com/company/bristows/
- Bristows Website : https://www.bristows.com/
- Bristows Blog post on UKCA: https://www.bristows.com/news/will-we-ever-see-a-ukca-mark-for-medical-devices/#:~:text=Currently%2C%20the%20UK’s%20medical%20device,conformity%20marking%2C%20the%20UKCA%20mark
- UKCA future implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations
- Infographics timeline: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1164062/Infographic_-_Devices_transition_timeline.pdf
- How to register a Medical Device in the UK: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
- Your UK Responsible Person: https://easymedicaldevice.com/uk-responsible-person/