Brexit Roundtable: The UK exit from the EU will take place in April 2019. The EU Regulation for MDs will be enforced from 2020, and that for IVDs from 2022!
When: 17 May 2018, 13.30-18.30
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE, United Kingdom
The point of view from pertinent stakeholders (Competent Authority, Industry, Legal, Hospital Supply Chain and Patients), followed by workshop and a panel discussion about your perspectives and open questions ready for “B-Day” and beyond.
What is it
The UK exit from the EU enforced on the 1st April comes at a time when Europe is full of great change pertaining to the medical device industry, particularly with the introduction of the new EU Medical Device Regulation (MDR), the In Vitro Diagnostic (IVD) regulation and the update to ISO 14155.
This year in early January, the European Commission issued a notice to stakeholders stating that the UK Competent Authority and Notified Bodies will lose their status in regard to regulation of EU devices and IVDs from 31st March 2019. Although negotiations between the UK and the EU are still in process (officially until 20th March 2019), meaning there could be a range of possible outcomes, there can be no reliance on any new arrangements to soften the harsh realities of a “Hard Brexit”
There is currently no mechanism for transferring EU regulation on MDs and IVDs into UK Law!
Until the advent of Brexit, UK was contributing around one third of the regulatory effort for Medical Devices distributed in the EU. Post Brexit, UK-based consultancies and Notified Bodies will find themselves straddling the separated regulatory systems for the EEA and for the UK. Furthermore UK Manufacturers may well expect to pay a tariff (circa 20%) for services leading to distribution of UK products in the EU.
Hear from the Experts, but also take the opportunity to raise your own questions and join in the debate.
- Find out how the MD and IVDs Sector is preparing for Brexit and the new Regulations?
- What can be done to prevent investment in UK-based R&D of devices being moved elsewhere?
- How can UK and EU-27 citizens be assured that there won’t be shortages of MDs and IVDs and delays in bringing innovative new products to the market?
Speakers include
Neil Armstrong, Meddiquest
Graeme Tunbridge, MHRA
Alison Dennis, Fieldfisher (Law Firm of the Year 2017)
Rod Ruston, Priory Analysts
How do I apply?
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Simply loginor create an account and register below.
Course fees:
Type |
Member |
Non-member |
Standard |
£150+VAT |
£250+VAT |
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Special offer!
If you subscribe to all three Roundtable meetings, on a personal-name basis, you will receive a discounted rate:-
www.topra.org/rtjune2018
Roundtable Two: Pharmaceutical New Product
Applications and MA Lifecycle Management - The Clock is ticking. Should alarm
bells be ringing?
www.topra.org/rtjuly2018
Roundtable Three: Pharmaceutical Clinical Development/EU Clinical Trials
Regulation – A Dire Need for Headache Pills!
Members: £400 + Vat (a saving of £50 + Vat)
Non members: £675 + Vat (a saving of £75 + Vat)
Please contact sarah@topra.org for the discount code.
Terms and conditions apply:
- Your place under this offer is not transferable
- Cannot be used in conjunction with any other offer
- Offer valid until 17 May 2018