Regulatory Open Forum

 View Only
Expand all | Collapse all

Brexit Impact on Clients of UK Notified Bodies

  • 1.  Brexit Impact on Clients of UK Notified Bodies

    Posted 24-Jun-2016 17:19
    In light of the Brexit vote, does anyone have any insight or any thoughts on what might happen to UK notified bodies' standing in the EU with respect to medical device regulation and to companies that have CE marks with UK notified bodies?

    --
    Julie N. Broderick, RAC
    Broderick Regulatory Consulting, LLC
    P.O. Box 903
    Winchester, MA 01890
    Tel: 781-254-5094


  • 2.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 24-Jun-2016 21:30

    I posted a similar question to the LinkedIn Medical Devices group, but haven't gotten any useful responses so far.

    I was surprised that there was so little discussion of the topic today, in this forum and in the LinkedIn Groups.  I got up this morning expecting everyone in medical devices to be talking about it.  But maybe they were busy on the phone with their stockbrokers. :)

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 3.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 08:15

    Here is the statement link from the MHRA

    Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendum - News stories - GOV.UK

    Www remove preview
    Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendum - News stories - GOV.UK
    The Agency's response to the outcome of the EU referendum.
    View this on Www >
    ------------------------------
    Beverly Whitaker
    President
    Indigo Consulting Group LLC
    Beaufort SC
    United States



  • 4.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 09:42

    Here's the link to BSI's statement, which has a bit more substance to it:

    http://www.bsigroup.com/en-GB/about-bsi/media-centre/EU-referendum/

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 5.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 24-Jun-2016 23:48
    Julie,

    I have a lot to say about "BrExit."  I wanted to ask you a provocative question: at this point, what/why do you care? 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567






  • 6.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 25-Jun-2016 10:06

    "Care" may be a bit of an overstatement, but my own interest in the question was originally inspired by a set of design dossiers that I put together a few years ago to secure CE certification for a line of Class III products.  Those certificates were issued by BSI and will expire late next year.  

    As I was watching the vote Thursday night, I started to wonder if BSI would still be a notified body late next year.  My guess is yes, but still, the question occurred to me.  Then I started thinking about how many gazillion medical devices that currently carry the CE mark are probably supported by a BSI certification, and which are set to expire at various times over the next five years.  Sounds like potentially a mess to me, and I wondered if others here who have CE certification responsibilities and work with BSI (or one of the other MHRA-designated NBs) had some thoughts on the matter.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 7.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 25-Jun-2016 12:56
    Julie,

    Greetings!  My post was directed to the other Julie. But I care and respect your comments.

    My views are: 

    To the UK's MHRA

    - It is recommended that the MHRA should establish its own medical device approval/registration system within the principles of the EU's medical device regulation or recognize other CE-marked devices available in the EU.
    - Develop a process of recognizing other CE-marked devices
    - Develop its own system for managing clinical trial data and require compulsory requirements to disclose clinical trial data so that it can enforce a maximum level of transparency (T), accountability (A) and responsibility (R).
    - It has to be done in phases in few years.
    etc.  

    I hope that the MHRA/UK can (try to) develop the world's best regulatory system, strongly enforcing TAR.

    To the BSI

    - As the BSI must work with the MHRA, I hope the BSI can quickly communicate its plan on how the UK/MHRA's regulatory system can/may impact to the CE-marked devices through the BSI.
    - Whatever the UK/MHRA adopts a system, the BSI should convince the MHRA to adopt a system without unduly impacting the CE marked devices through the BSI.
    - If impacted, it should be done so in phases, enabling some to transfer to other NBs. 
    etc.

    If the UK/MHRA or the BSI needs some advice based on what I have seen from failures or successes, they may contact me. 

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 8.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 25-Jun-2016 17:47

    Hi, just from the top of my head, we probably will see an RAC Uk, like the EU, Canada, or maybe will fall under Global! i think not very much changes will take place in regulatory immediately, the ISO certification will dominate, and until they sort the situation with Scotland etc.. that will take time, I believe....but like the Doctor said who cares at this moment?

    Sol, 

    ------------------------------
    Zolik Schperberg
    Quality Assurance III
    San Diego CA
    United States



  • 9.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 26-Jun-2016 03:49

    BSI is releasing it's official statement to all existing clients tomorrow 27 June 2016 in response. The short answer - yes BSI will remain a Notified Body of the EU. 

    ------------------------------
    Timothy Lee
    Seattle WA
    United States



  • 10.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 26-Jun-2016 10:01

    While I personally expect BSI to remain an NB, I will be surprised if that is what they say in their official statement. 

    No organization gets to decide whether it can be, or can remain, an NB.  The best that BSI can do is to lobby for the attention of the appropriate authorities amidst the Brexit chaos to get them to focus on the need to identify the path by which BSI and other MHRA-designated NBs can remain NBs, to assure clients that BSI can and will pursue that path, and then pursue it.

    Based on my (extremely limited) understanding of the previously obscure, now infamous Rule 50, it seems BSI has up to two years to do this, since it seem clear to me that BSI will remain an NB as long as the UK remains in the EU.  Whatever BSI's statement says tomorrow is probably much less important than the fact that it has a statement ready for release two business days after the exit vote.  The important message is that BSI is on it, in which case two years should be more than enough time to get the bureaucracy sorted out.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 11.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 02:10

    As long as a BSI subsidiary is registered as a NB in an EU member state they remain a NB

    Given that there are not enough NBs I wouldn't worry

    The UK government hasn't even officially started the leave procedures, which must take a minimum of 2 years according to the treaty of Lisbon

    Siegfried

    ------------------------------
    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
    siegfried.schmitt@parexel.com



  • 12.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 28-Jun-2016 07:50

     

    Email not displaying correctly?
    View it in your browser.

     

     

     

     

     

    BSI Medical Devices

     

    Client Communication EU Referendum:  27th June 2016.
     
    Dear BSI Client,

    BSI's role as an EU Medical Devices Notified Body

    BSI's role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to enable BSI to continue being recognized as a Notified Body for Medical Devices. 

    BSI fully anticipates we will remain a long term major EU Medical Device Notified Body as there are established well recognized existing mechanisms in place for non-EU countries to participate as EU Notified Bodies. For example, the designated organizations in Norway (under EEA recognition), Switzerland and Australia (through Mutual Recognition Agreements) are recognized as Notified Bodies for the purposes of the relevant EU legislation.

    We will continue to keep you updated on a regular basis as the political situation develops and discussions progress.  For now, it's business as usual and most importantly, we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.
     
    To read this communication in another language please click on the country flags below.

                   
    http://pages.bsigroup.com/l/43652/2016-06-24/dj6cw1/43652/110968/france_flag.GIF                    http://pages.bsigroup.com/l/43652/2016-06-24/dj6cw3/43652/110970/germany_flag.gif                    http://pages.bsigroup.com/l/43652/2016-06-24/dj6cvy/43652/110966/italy_flag.gif  

                   
    http://pages.bsigroup.com/l/43652/2016-06-24/dj6cw5/43652/110972/japan_flag.gif                    http://pages.bsigroup.com/l/43652/2016-06-24/dj6hty/43652/110988/SPANSIH_FLAG.PNG                    http://pages.bsigroup.com/l/43652/2016-06-27/djdm6c/43652/111040/CHINESE_FLAG.PNG

    To help you keep up-to-date with the latest developments and discussions, please visit our dedicated web page.

    Thank you for your continuing support.
    Yours faithfully,
     
    Gary Slack
    Senior Vice President
    Global Medical Devices & Healthcare

     

    http://pages.bsigroup.com/l/43652/2014-11-19/2c9cw/43652/37634/linked_in.gifJoin our LinkedIn group to keep up to date with relevant news

     

     

    Dennis Hahn
    Director, Regulatory Policy Innovation, Ethicon

    image001.jpg@01D0B3E8.FC533340

    4545 Creek Road | ML 20 | Cincinnati, Ohio 45242
    513.337.3134 phone | dhahn1@its.jnj.com

    Confidentiality Notice: This e-mail transmission may contain confidential or legally privileged information that is intended only for the individual or entity named in the e-mail address. If you are not the intended recipient, you are hereby notified that any disclosure, copying, distribution, or reliance upon the contents of this e-mail is strictly prohibited. If you have received this e-mail transmission in error, please reply to the sender, so that Johnson & Johnson can arrange for proper delivery, and then please delete the message from your inbox.

     

     






  • 13.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 10:03

    BSI's role as an EU Medical Devices Notified Body

    BSI's role as an EU Notified Body will not change following the recent decision of the EU referendum while the UK Government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) to enable BSI to continue being recognized as a Notified Body for Medical Devices. 

    BSI fully anticipates we will remain a long term major EU Medical Device Notified Body as there are established well recognized existing mechanisms in place for non-EU countries to participate as EU Notified Bodies. For example, the designated organizations in Norway (under EEA recognition), Switzerland and Australia (through Mutual Recognition Agreements) are recognized as Notified Bodies for the purposes of the relevant EU legislation.

    We will continue to keep you updated on a regular basis as the political situation develops and discussions progress.  For now, it's business as usual and most importantly, we would like to assure you that BSI will continue to provide EU market access as we have done since the inception of the three EU Medical Device Directives.

     

    Paul C Brooks

    Senior Vice President, Healthcare Solutions

     

    T: +1 703 464 1923 | M: +1 571 216 9071 | F: +1 703 437 9001

    paul.brooks@bsigroup.com | Skype: paul_c_brooks

     

     

     

     

     

     


    BSI Group America Inc, 12950 Worldgate Drive, Suite 800, Herndon VA 20171 USA | http://medicaldevices.bsigroup.com/en-US/

     

    *** Please note that whilst we are willing to give any help and advice we can, any views given by us on the interpretation of medical device regulations represent our best judgement at the time, based on the information available. Such views are not meant to be a definitive statement of law, which may only be given by the Courts. Accordingly we would always advise you to seek the views of your own professional advisors. ***

     

    P Please consider the environment before printing this email

     


    ________________________________________________________________________

    Visit the BSI website at www.bsigroup.com

    This email may contain confidential information and/or copyright
    material. This email is intended for the use of the addressee only.
    Any unauthorised use may be unlawful. If you receive this email
    by mistake, please advise the sender immediately by using the
    reply facility in your email software.

    The British Standards Institution is incorporated by Royal Charter.

    This email has been scanned for all known viruses.





  • 14.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 10:13
    Hi Paul,

    I may show up and knock on your door (in my own mind) to verify whether the BSI has implemented a "Contingency Plan", the plan of which provides detailed procedures on how to deal with and/or respond to any (public) inquiries either solicited or non-solicited.

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 15.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 14:57

    I just tried to access BSI's statement and got a blank...the title "EU Referendum Results" is there, but no text?

    http://www.bsigroup.com/en-GB/medical-devices/news-centre/EU-referendum/

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 16.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 28-Jun-2016 10:33

    Thank you for chiming in here, Paul.  I am glad to see that BSI has made a statement and that the future impact to BSI clients appears to be minimal.  Thanks to everyone in the RAPS community for participating in this discussion and sharing information.

    ------------------------------
    Julie Broderick RAC
    Principal/Consultant
    Broderick Regulatory Consulting, LLC
    Winchester MA
    United States



  • 17.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 26-Jun-2016 08:43

    As much as some non-EU countries adopt EU guidelines and regulations, an independent United Kingdom (Great Britain and Northern Ireland) can decide to continue to adopt and comply with EU regulations in just the same way. Be it for Notified Bodies or others.

    Thus, there is little reason for concern

    In any case, we're still an EU member, they haven't let us go yet

    Siegfried

    ------------------------------
    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
    siegfried.schmitt@parexel.com



  • 18.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 26-Jun-2016 11:43

    Yes,  an independent UK can decide to do a lot of things, but it still has to make the decision and then do whatever it decided to do.  Democratic governments are rarely characterized by speedy decisions or actions.  (When we in the US say that something "would take an Act of Congress," we don't mean it is something that is likely to be easy or fast.)

    But I should clarify that my perspective is most commonly that of a Class III start-up.  Their burn-rate and the financial consequences of a product failure dictates that pretty much everything is a reason for concern.  The typical device company often has little reason to share the same concerns.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 19.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 09:54

    And from that perspective, having this timing overlap with that of the EU implementing the new MDR will present a lot of complexity for BSI clients.

    Ginger

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States



  • 20.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 14:36

    "When worlds collide" keeps running through my head.  I think a lot of implementation timelines are going to run smack into each other...Brexit, MDR/IVDR, redesignation of NBs, etc.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 21.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 16:31
    Julie,

    When running a country, it is common to implement a contingency plan in view of any potential outcome.  The UK government must have done so!  

    It is known that the UK is not ready to begin the process and thus, they need some time.

    One thing I was expecting from the BSI is that the moment the referendum result is out, the BSI could have issued their contingency plan within 15-30 min.  The plan of which should have been worked out in view of the potential referendum outcome. That wasn't the case.

    When I provide guidance to my global audience, I emphasize that we should be ready, willing and able to deal with any matter under any possible, situated circumstances "even if we don't know what we don't know at the time."

    Please enjoy watching how the process at the UK unfolds.

    FYI: 26 years ago, I used to work for the grandson of the king of Scotland.  He is now a cardiologist in Ohio, US.

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





  • 22.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 22:35

    How common it is, I can't say, but, I agree that all organizations (and individuals too) would be wise to engage in ongoing contingency planning.

    At two business days out, yes, it seems possible that BSI neglected to establish a contingency plan for Brexit, and therefore a number of people probably lost a lot of sleep between midnight on Thursday and Monday morning.  On the other hand, it's also true that nothing is going to change over night, so, for all practical purposes, today was soon enough. 

    One thing gained by waiting a bit was an opportunity to refine the assumptions underlying the contingency plan before rolling out their response.  On Friday, everyone finally found out, for example, exactly how much the value of the pound and the stock markets would be affected, rather than best-guessing.  Also, there are a lot of players in the mix, so BSI got a chance to see something of what the other players would actually do after a Brexit vote, again, rather than best-guessing.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 23.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 10:05
    Hi David,

    I care because I have several clients who are with a UK notified body, and it would be useful to know for planning purposes what's going to happen to their standing with respect to CE marking, particularly in light of the new medical device regulation.  Will these companies need to switch notified bodies soon or when the MDR goes into effect?  Will their existing CE marks continue to be recognized in the EU and for how long?  Will there be a separate medical device approval process in the UK after the exit is completed.

    Lots of uncertainty!

    Julie

    --
    Julie N. Broderick, RAC
    Broderick Regulatory Consulting, LLC
    P.O. Box 903
    Winchester, MA 01890
    Tel: 781-254-5094





  • 24.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 10:16
    Hi Julie, your concerns with care sound very reasonable, legitimate and thus, are well taken. Thank you.  David





  • 25.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 27-Jun-2016 14:08

    Here are links to some thoughtful analyses posted to one of the medical device linkedin groups:

    https://www.linkedin.com/pulse/brexit-ce-mark-implications-european-regulation-arthur-brandwood

    https://medicaldeviceslegal.com/2016/06/26/medical-devices-and-the-brexit/

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com



  • 26.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 28-Jun-2016 08:29

    I wanted to pass this Article along that I read this morning - just giving some more insight on what we may see down the road. 

    ------------------------------
    Christine



  • 27.  RE: Brexit Impact on Clients of UK Notified Bodies

    Posted 29-Jun-2016 08:37

    I think this is a reasonable question.  I was wondering the same thing.  . 

    ------------------------------
    Alison Trado
    Regulatory Affairs Specialist
    Catalent - ENTERPRISE
    Somerset NJ
    United States