We have submitted applications for the Medical Devices Directive and the In-Vitro Diagnostic Devices Directive in the Netherlands. 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).
If, in the worst-case scenario, our application is not approved in time and in, what we view as the highly unlikely event 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).
We note you have applied for Notified Body status in the Netherlands. When are you expecting to know the outcome of your application?
The complexities involved mean that IGJ is unable to provide us with a definitive timeframe for completion of the process to notification.
While we cannot guarantee a successful transition of our Notified Body entity from the UK to the Netherlands in advance of the 29 March 2019 deadline, we are in constant communication with the IGJ and will keep our clients updated with any significant developments.
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.