What should you know on UKCA extension скачать в хорошем качестве

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 a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. -------------------------------------------------------------------------------------------- ► Links from the Video ■ Alex Denoon Linkedin :   / alexdenoon   ■ Bristows law firm linkedin page:   / bristows   ■ Bristows Website : https://www.bristows.com/ ■ Bristows Blog post on UKCA: https://www.bristows.com/news/will-we... ■ UKCA future implementation: https://www.gov.uk/government/publica... ■ Infographics timeline: https://assets.publishing.service.gov... ■ How to register a Medical Device in the UK: https://www.gov.uk/guidance/regulatin... ■ Your UK Responsible Person: https://easymedicaldevice.com/uk-resp... ------------------------------------------------------------------------------------------- ► Social Media to follow ■ Monir El Azzouzi Linkedin:   / melazzouzi   ■ Twitter:   / elazzouzim   ■ Pinterest:   / easymedicaldevice   ■ Instagram:   / easymedicaldevice   ------------------------------------------------------------------------------------------ #easymedicaldevice #medicaldevice #regulatorycompliance