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Brexit impact in relation to Medical Device Directives

We are firmly committed to remaining a major EU Medical Device NoBo and have developed several potential solutions for how this will be achieved depending on the final agreements made between the EU and UK.

We have submitted applications for the Medical Devices Directive and the In-Vitro Diagnostic Devices Directive in the Netherlands. We have now been advised that our assessment date with the Dutch Competent Authority (Inspectie Gezondheidszorg en Jeugd, IGJ) will be mid-March. Therefore we expect our entity in The Netherlands to become an approved EU Notified Body between June and September 2019. Further information in relation to our assurance services serving the medical device arena can be found here.

In addition to pursuing EU NoBo appointments to maintain support for our clients to access the European markets, we will also work closely with UK regulatory bodies to enable us to continue to support clients in accessing UK markets post-Brexit.

Management systems training and management systems accredited certification are unaffected by Brexit.

While UK and EU government negotiations continue, we will keep medical device companies updated on this page. 

  • What will LR do in the event of a hard Brexit?

    Any form of Brexit which does not include plans to allow UK Notified Bodies to continue to provide their clients with CE marking services could directly lead to the risk of patients’ lives in the UK and EU.  We believe it is therefore extremely likely that the UK Government and the EU Commission will forge a suitable agreement with the EU27 to prevent this from happening.

    However, LR has tried to make every provision to safeguard our clients’ needs and has submitted an application to the Dutch Competent Authority (Inspectie Gezondheidszorg en Jeugd, IGJ) for appointment as a Notified Body in the Netherlands. This will enable us to provide identical services to those we currently provide through our UK Notified Body, for Medical Devices (93/42/EEC) and In-Vitro Diagnostics Devices (98/79/EC).

    We still believe that a “hard” no-deal Brexit with no accommodation for critical areas such as medical devices on 29th March is unlikely. If, in the worst-case scenario, our application is not approved in time and in the case of a hard Brexit, then we would be unable to provide Notified Body services for products entering the EU27 or UK markets. Currently issued LR certificates would, in this scenario, cease to be valid with effect from the withdrawal date (30 March 2019 00:00 hrs CET).

    As the implications of such a situation are unprecedented, we would not expect such a situation to occur but if the likelihood increases, we would notify our clients immediately.  The fact remains that due to the number of devices potentially affected and the timescales involved, a switch to an EU27 Notified Body is not necessarily a viable option.

  • What happens to LR’s Notified Body status in the event of a soft Brexit?

    It is our understanding that this scenario includes an implementation period in which the conformity assessment regime remains unchanged. Therefore, conformity assessment by LR will continue to be recognised in the EU in the short term. One possible outcome is that the mutual recognition of Notified Bodies will be included in the proposed transition agreement, covering the period until December 2020. We understand that discussions also include the possibility of a permanent mutual recognition scheme forming part of the final agreement but this is speculation at this time.

  • What has LR done to ensure minimal or no impact for clients in the face of a hard Brexit?

    LR is actively engaged with EU and UK stakeholders to ensure that the impact of a hard Brexit on our clients – and their clients i.e. the wider public – is fully understood and considered before any decision is made.

    We have submitted an application to the Dutch Competent Authority (Inspectie Gezondheidszorg en Jeugd, IGJ) for appointment as a Notified Body in the Netherlands. When our status as a Notified Body in the Netherlands is confirmed, this will enable us to provide identical services to those we currently provide through our UK Notified Body for Medical Devices (93/42/EEC) and In-Vitro Diagnostics Devices (98/79/EC).

  • UPDATE: We note you have applied for Notified Body status in the Netherlands. When are you expecting to know the outcome of your application?

    We have now been advised that our assessment date with the Dutch Competent Authority (Inspectie Gezondheidszorg en Jeugd, IGJ) will be mid-March. Therefore we expect our entity in The Netherlands to become an approved EU Notified Body between June and September 2019.

    In the event of a no-deal Brexit

    We still believe that a “hard” no-deal Brexit with no accommodation for critical areas such as medical devices on 29th March is unlikely. Indeed you may have noted reports in recent days suggesting that the EU and UK may yet agree to delay the UK’s departure date by a few months. 

    But, should the UK leave the EU without a deal, whether on 29th March or at a later date:

    • Current CE certificates will continue to have validity in the UK, allowing products to be placed on the UK market and the MHRA will carry on overseeing the activities of UK Notified Bodies.
    • Current CE certificates issued by Lloyd’s Register (and other UK Notified Bodies) will cease to be valid for the placing of products on the EU market from the date of the UK’s departure from the EU.

    In the event of a hard Brexit, it is likely that the EU and the UK will make provision for medical devices recognising their safety-critical nature. It is our understanding that contingency planning by UK regulators and the EU Commission has included discussion of transitional arrangements under which current CE certificates would continue to be recognised by the EU for a defined period, in order to protect the supply of critical products to Europe.  While such discussions are ongoing. it is an encouraging sign and indicates that the severity of the implications of an interruption to the supply of critical products is understood by all stakeholders.

    Due to the number of devices potentially affected and the timescales involved, transferring to an existing EU27 Notified Body is not a realistic option at this time.

    Guidance from the regulator

    More information can be found in the MHRA’s recently published technical notice.  Please note that the MHRA suggests manufacturers contact the competent authorities in those countries where they supply large volumes of critical product, for a country-specific update on the situation in the event of a no-deal Brexit.

  • Can we transfer to an alternative Notified Body?

    Our discussions with key stakeholders leads us to believe that a successful transfer to another Notified Body would be highly unlikely before a hard Brexit deadline. This uncertainty, combined with the disruption for your organisation, as well as the time involved in the process, would severely limit the likelihood of a successful transition.

  • How much will it cost to transfer from LR in the UK to an alternative LR body?

    It is our intention to transfer clients’ approvals from our UK Notified Body to that in the Netherlands with minimum cost once we obtain appointment in the Netherlands. We are discussing the transfer process with the Dutch authorities and will let you know developments as they arise.

  • As we are only allowed to be registered to one NB, technically, we wouldn’t be able to hold differing UK and EU CE numbers for LR. How would this issue be solved?

    A key element in our approach is to ensure that our Notified Bodies in the UK and the Netherlands work to identical processes and procedures. This will make the transitioning of clients’ certificates from one body to the other as straightforward as possible. The transfer of your certificate from our UK Notified Body to our Dutch Notified Body, will include a new EU CE number which then fully replaces your existing certificate issued from our UK-based Notified Body.

  • What is LR’s current position? Our MD comments…

    The uncertainty around Brexit continues. The UK and EU are still to finalise an agreement for the UK to withdraw from the EU.  

     

    LR’s position remains unchanged - we are still firmly committed to remaining a major EU Medical Device Notified Body and are currently awaiting an audit date with regards to our applications for the Medical Devices Directive and the In-Vitro Diagnostic Devices Directive in the Netherlands. 

     

    Paul Butcher, Managing Director Business Assurance and Inspection Services at Lloyd’s Register, gives his opinion on the uncertainty surrounding Brexit and what he believes will be the most likely outcome for the medical devices industry: 

     

    “There is still a great deal of uncertainty about what will happen – and almost every scenario possible has been discussed recently. Whilst the Government, under Theresa May’s leadership, remains committed to acknowledging and upholding the public vote adhering to the “Brexit means Brexit” stance it has held over the last two years, there is a clear lack of support for this position within parliament.  

     

    “The risks associated with a  ‘no-deal’ hard Brexit are increasingly recognised. Despite Parliament’s lack of support for the current Brexit agreement, and the weakening leadership position within the Conservative Party, I believe this is an unlikely outcome. The recent ruling by the European courts that the UK can unilaterally delay, or even cancel, the Brexit date and remain in the EU on the current treaty terms is important.  When, or if, the current discussions between the UK and EU fail to deliver any material change to the agreement then the pressure to “buy more time” to either negotiate an alternative exit with an associated trade agreement, or to have another referendum, will increase.  

     

    “However, if the worst-case scenario of a hard Brexit does become likely then, given the impact that this will have both in the UK and EU, I believe transition agreements are likely to be implemented in critical areas such as medical, transport and food in order to allow time for the development of more permanent solutions. 

     

    “We are actively urging decision makers to recognise the medical device industry as one that must be prioritised because of the threat to life across Europe. There simply isn’t time for all devices to be transferred to a European Notified Body – it’s a huge piece of work for all companies involved. The fact that the industry has moved from a Directive to the Medical Device Regulation (MDR) further complicates matters and the scale of what needs to be done is enormous and not something that takes weeks. The reality is it will take months, perhaps even years and it makes absolutely no sense to not take that into account. Deferring the impact of a hard Brexit and implementing a mutual recognition agreement is the most sensible option. Even so, we continue to push forward with our contingency plans to obtain notification within the EU 27. 

     

    “Emotions are still running high and the uncertainty and lack of clear direction is incredibly frustrating. Despite this, I am optimistic the UK Government and EU Commission will take pragmatic action and forge an agreement to mitigate any risks in the medical device industry – and by doing so, safeguard people living in the UK and across Europe.”

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