Gary Slack

Pharmaceutical Industry 1981 -1994

Novartis AG /Merck Inc./Purdue Frederick Inc.

Medical Device Manufacturing Industry 1994 – 2008

10 years Medtronic:

National Sales Manager Interventional Cardiology

Sales Director Cardiac Rhythm Management (UK)

General Manager Vitatron UK & Ireland (Medtronic Group Company) 

3 years Boston Scientific:

Business Unit Director Cardiac Rhythm Management (UK & Ireland)

BSI Group 2008 to Date

2008

Business  UNIT Director Medical Devices: With responsibility for all EU Notified Body activity including: Manufacturing Site Audit & Assessment, Product Certification to meet EU Medical Device directives (CE) and all Medical Device Certification Approval Body (CAB) activities globally.    

2014 -2017

Senior Vice President – Global Medical Devices and Life sciences (Washington DC USA). Full P&L responsibility for all EU Notified Body activity including: Manufacturing Site Audit & Assessment, Product Certification and all other Global Medical Devices CAB services.

January 2018 

Senior Vice President – Global Medical Devices –Relocated back to the UK

W ith 45% of devices accessing the EU via UK NBs, what would be the impact of a so-called “hard Brexit?” The political landscape is far from clear. However, BSI would concur with the recent MHRA paper as we fully anticipate remaining part of the EU system for the long term. We also agree that nothing will change during the implementation period to 31 st December 2020. Netherlands – BSI Designation There is much discussion and we are very pleased to confirm BSI is almost complete in our MDD /AIMD application with a target date we are working towards agreed between BSI NL and IGJ of Q3 2018 for MDD/AIMD designation. With this in mind, if driven by a “non-negotiated” or “hard” Brexit outcome, there is a need to rapidly migrate CE certificates to the Netherlands. We have a relatively straightforward process (this does not require additional conformity assessment) agreed and the plan is resourced to deliver the change within the required timeframe. We have shared this information with our clients around the globe. If there is a non-negotiated Brexit outcome resulting in the need to migrate all certificates to the new NL NB, the advice we have received from IGJ (NL Healthcare Inspectorate), NL Ministry of Health and the EU Commission, is that a new NB number relating to our NL designation is required and it is not possible to retain our existing NB 0086 number. (BSI does however plan to retain the existing certificate number). Whilst this raises the spectrum of potentially requiring additional resources for relabelling, BSI can confirm that the relabelling requirements normally associated with transfer from other EU Notified Bodies can justifiably be prolonged (NBOG BPG 2006-01). This has been discussed with the Designating Authority in both our initial designation Joint Assessment and recent follow-up...
It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/746 were able to submit formal applications. The date of application of the MDR and IVDR, 27 th May 2020, is currently 20 months away. I would like to publicly acknowledge the significant effort and singular focus of the Competent Authorities (CA) to progress applications and meet the forthcoming deadlines. Given the hiatus before any applications could be formally submitted in November 2017, even the earliest NBs are unlikely to be designated until 2019 – leaving just one year remaining of the original three-year transition period. For BSI, our contact is with our primary CAs the MHRA (UK) and IGJ (NL). Both have been extremely supportive. BSI submitted its applications on day one for both regulations in both jurisdictions. The response from the MHRA was equally rapid and we were fortunate to be the very first NB to undergo MDR JA in early April this year. The MDR/IVDR Commission & Competent Authority Joint Audit (JA) of NB is a crucial process. However, there is concern, regarding the availability of resources given the need to handle all applicant NBs in a timely manner. Recent data published by The European Association for Medical Devices of Notified Bodies (TEAM NB) in July 2018 suggest 11 JAs are currently in the diary (six completed, four scheduled and one with a date to be confirmed). A further five NBs expect to submit this year. So, what are the implications for market access and, more importantly, patient care? Here are what I see as the three primary issues: 1. Many NBs (circa 16) are not ready to apply in 2018. Recent data from the European Commission DG SANTE corroborates Team NBs data...