We are hosting a webinar discussing how to successfully navigate the medical device industry’s regulatory challenges for medical device companies looking to sell their product into UK markets.
From 1st January 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) has become responsible for the UK medical device market. New regulations will require all classes of medical devices to be registered with the MHRA, and manufacturers based outside the UK will need to appoint a UK Responsible Person to register devices. An additional complexity is that rules for Northern Ireland differ to the requirements in England, Scotland and Wales.
Richard Tully of Compliant Medical Devices, a leading expert in EU regulations and law, with 20 years working within the medical device industry, will be the guest speaker. Richard has taught technical and quality aspects of the law worldwide to the public, companies, Notified Bodies and Competent Authorities.
The webinar is being held on Thursday 14th January 2021, at 11:00 EST / 08:00 PST (16:00 GMT / 17:00 CET) and will cover the following topics:
– Requirements for manufacturers selling into Great Britain and Northern Ireland post-Brexit
– How this compares to requirements for the EU
– Timelines for meeting the requirements of UK and EU law
Register for the webinar via the following link – https://app.livewebinar.com/350-702-647/x/LciUJGYZ
If you have registered for the webinar but are unable to attend, a recording will be made available after the session for you to watch.
Quote from Matt Woods, founder: “The UK medical device market is the third-largest in Europe, and the sixth-largest in the world. Now that the UK has officially left the EU, understanding how to navigate and access the orthopaedic and spine market in the UK Post-Brexit is a business-critical topic. I’m looking forward to this webinar, which will be the first in a series hosted by Ortho Consulting Group this year”.
Quote from Richard Tully: “Business needs to respond quickly and effectively to regulatory changes in the UK. This webinar will lay out the requirements to be met by manufacturers. Over the last three years, device manufacturers have been gearing up for the MDR and the IVDR. Brexit has thrown a spanner into one-seventh of the market. This webinar will clarify what this means in meeting UK law as opposed to EU law.”