The next Medtech Regulatory Special Interest Group (SIG) will take place online. Join us as we help you to get to grips with the new UKCA Marking requirements in this post-Brexit era. Important new obligations apply for all Medical Device and IVD businesses and it is vital for companies to understand what they have to do and when, the first milestone deadline is 30th April 2021 so you can’t afford to miss this.
The topics being discussed are:
-Trading within the UK and between the UK and Europe just got more complicated?
-The United Kingdom of Great Britain & Northern Ireland
-The new UKCA Mark, what are the rules now?
-Product and Company Registrations
-Timelines and Deadlines
-UK Responsible Person & Authorised Representative
-UK Approved Body vs Notified Bodies
-Quality Management Systems
-UK Designated Standards
-Multiple Markets
-Labelling Changes
There will also be an opportunity to ask the presenters questions in a Q&A session.
DURATION: 1 hour 30 minutes
This free to attend event is held as part of the ACTIS programme – a project part-funded by the European Regional Development Fund, click here to be re-directed to further information about the project. This event is classed as State Aid to participating businesses, the value of which is £190, but is delivered completely free of charge to participants.
Speaker Profiles
Peter Rose, Managing Director, PRQR Ltd (Chair)
Peter is the founder of PRQR Ltd. With 26 years of experience with Medical Devices and IVDs, Peter has expertise covering Quality Assurance, Regulatory Affairs, Sterilisation, Cleanrooms and Contamination Control. He is a Microbiologist, Chartered biologist, Member of the RSB, Practitioner Member of the CQI and a Member of TOPRA
Ed Wright, Partner, Shakespeare Martineau
Ed works with clients from all sectors including life sciences and technology, media and telecoms on wide-ranging non-contentious commercial, contractual, IP, ICT, e-commerce, data protection, competition and public procurement law issues. He advises on IP creation, ownership, protection and exploitation, including technology transfers, R&D collaborations and agency, distribution/reselling and franchising arrangements.
Ed has a keen interest in drafting/advising on IP licensing arrangements and, whenever possible, presents and writes on topical commercial and/or IP matters.