ABHI/BIVDA/MHRA/UKNBG Tripartite

MD Brexit Working Group

Minutes of Meeting 30th June

ABHI, 107 Gray’s Inn Road, London WC1X 8TZ

Attending Apologies

Mike Kreuzer (MHK) ABHI Andy Vaughan (AJV) ABHI

Clive Powell (CMP) ABHI James Halliday (JH) Acelity

Phil Brown (PMB) ABHI Cait Gatt (CG) Boston Scientific

James Comper (JC) Alcon

Donna Vinnels (DV) Baxter

John Walker (JW) C R Bard

Noinin Reynolds (NR) DCC Vital

Lynn Heaver (LH) Johnson & Johnson

Jim Baker (JB) Renishaw

ACTIONS LH chaired the meeting.

09/17 Competition Law Reminder

The group was reminded of the rules governing discussion of sensitive topics in ABHI meetings. Members signed the attendance sheet indicting that they had read and understood their responsibilities in relation to competition law.

[email protected] l_20170726_112015.pdf

10/17 Notes of Meeting 27.04.17

The notes were approved.

11/17 Actions from Meeting 27.04.17

07/17 a) MHRA Guidance Documents (virtual manufacturing & leadless pacing) PMB had raised this with John Wilkinson as potentially adding regulatory burden on companies in the UK. His answer was that MHRA was simply formally reiterating what they had been told by the Commission. However, while this might be the case it seemed that only the UK was doing this by such formal means. MHK reported that the feeling was that elsewhere in Europe the UK was being over-zealous on some of these issues. ABHI would continue to pursue these issues.

Related to this was that MedTech Europe was in the process of setting up a group to

ABHI MD Brexit Working Group Minutes of Meeting 30.06.17 1 Attending Apologies

look at own brand labelling and would first focus on procedure packs. JW reported that he had been asked to participate.

ABHI, in conjunction with BDIA, was to hold a virtual manufacturing seminar on 19th July at the offices of Bird & Bird. Dhruti Patel, Adrian Bartlett, Rob Higgins and Graeme Tunbridge from MHRA would all attend. Mary Ryan would be presenting and Martin Penver and Paul Sim would be on the panel.

07/17 b) Guidance for Members/FAQs DV had drafted a list of discussion topics where ABHI could usefully look to provide more information to members.

Brexit Discussion Topics - TPG WG v0.1.xlsx DV agreed to expand the document by adding some detail under each of the headings. She would also look to cover the implications for an SME and an international business. She would circulate the document for comment by the end of July in order that it could be finalised in good time for the MDILG meeting in September. DV CMP reported that he had received very few Brexit-related questions from members though it did come up fairly frequently in conversation.

MHK thought there was some crossover with topics that were being covered by the MDR Implementation WG. LH suggested that the groups should perhaps meet together from time to time.

12/17 Medical Device Industry Liaison Group

MHK reported that MHRA had received a new position from the Pharma industry following the general election and had asked ABHI to reconfirm the MedTech industry position on regulatory PMB aspects of Brexit. PMB agreed that we should revisit the relevant sections of the ABHI Healthy Outside the EU document. [LATER: PMB circulated wording to the group for comment prior to forwarding to MHRA – some changes were proposed and these would be circulated.] CMP

Regulatory touchpoints HOTEU 040717.docx With regard to relocation of EMA, apparently it was the Commission that was adopting an aggressive approach to getting this done as soon as possible (a decision by November was the goal); the Council and Parliament were more concerned to ensure that it was achieved with as little disruption as possible.

MHRA confirmed that the current UK device regulations would be included in the ‘Great Repeal Bill’

As far as the situation regarding the location of notified bodies and authorized representatives was concerned, the longer the situation remained uncertain, the more likely it was that those with the ability to do so would relocate to an EU member state or, at the very least, open an office there. The Commission was apparently checking the legality of a notified body retaining the same number if it were to move location and be designated by a different competent authority. It was suggested that MHRA should be made aware of the issues for companies, authorities representatives and notified bodies that continued uncertainty would bring.

ABHI MD Brexit Working Group Minutes of Meeting 30.06.17 2 Attending Apologies

MTE was considering the implications of a ‘hard Brexit’, though following the election result this looked a less likely scenario.

PMB agreed to draft a paper highlighting some of the issues discussed.

13/17 Other ABHI Brexit Initiatives

Earlier in the month ABHI joined the Brexit Health Alliance.

ABHI launched its International Membership category on 21st June.

06/17 MedTech Europe

PMB reported that MTE had held a round-table discussion with the Commission. They looked at the impact of Brexit from the point of view of European-based companies. The primary matter of interest was the status of the UK notified bodies. Also discussed were trade issues as well as supply of components and materials. The MTE National Association Network was also discussing Brexit matters.

07/17 Any Other Business

a) Ireland PMB suggested making contact with the Irish Association (actually there were two: the Irish Medtech Association – formerly IMDA, and IMSTA). He agreed to contact Aine Fox at Irish PMB Medtech.

NN said that Justin Carthy was the contact at IMSTA.

b) Clinical Evidence LH raised the possibility of the UK requiring clinical evidence from UK citizens post Brexit. She agreed to follow up on this with MHRA. LH

08/17 Date of Next Meeting

A conference call was scheduled for 14th August but for various reasons this was taken over by a TPG conference call. [CMP to look for another time]. CMP

A further meeting would be scheduled for September, possibly in conjunction with the MDR Implementation WG. CMP, LH, PMB

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