Urgent BREXIT Implications for Market Access - 60 Days Out from 29 March 2019
News: 29 January 2019
We are approaching the Article 50 BREXIT deadline and are now less than 60 days away from a potential hard Brexit; the 29 March 2019. When BSI initiated our NL contingency plan in August 2016, we could not have foreseen the lack of political progress. Given the current political impasse and following requested updates in the last week from both Competent Authorities for BSI, we have obtained critical information from IGJ /VWS in the Netherlands and the UK MHRA. We would like to provide a clear update to you on our discussions.
We specifically asked the Competent Authorities for the EC policy on migration and validity of CE certificates from a UK notified body post 29 March 2019, if Article 50 is enacted and applied on this date without an agreed transition deal.
The Competent Authorities advise:
a) As of 30 March 2019, the UK will become a third country and the CE certificates will lose their validity.
b*) However, very importantly, once CE certificates lose their validity post 29 March, they will not be able to be transferred or migrated to an EU NB. Products will lose market access, and a new conformity assessment will be required.
c) Cut off for the product will be based on whether the product is considered as having been ‘placed on the market’. This is not the regulatory definition but the more traditional definition used for product recall or vigilance. The product will be considered ‘placed on the market’ if before 30 March it is physically manufactured and shipped within the supply chain, for example, in a distribution warehouse (within an EU 27 member state) or the end user Hospital/Clinic etc. Product stored at the manufacturer's facility will not be deemed as having been placed on the market.
Action required by the manufacturer
BSI cannot mandate that you as a legal manufacturer migrate your CE certificates to our Netherlands NB, this is your own commercial decision, and we will follow your instructions into us, however, we would like you to be aware of the following view:
We very strongly recommend manufacturers migrate their existing BSI UK NB (0086) CE certificates to BSI NL NB (2797) as a matter of urgency.
Failing to complete migration of CE by 29 March creates a likelihood of interrupted market access, and as advised in ‘b*’ above, could lead to prolonged interruption and necessitate a full conformity assessment. BSI will take a centralized approach to the migration process to enable tracking and control; please request the “Migration Pack” details from the following email address > CEcert2NLNB@bsigroup.com
Return your migration packs as soon as possible to the migration team, currently our waiting time for migration is very short but this will increase as we near the Brexit deadline. We have added additional staff to undertake this work and are diverting significant resources from other activities to ensure we complete this activity for all BSI medical devices clients urgently.
We understand for manufacturers with multiple CE certificates and sites you may wish to involve your Scheme Manager. If so, please ensure that initial contact is through the central process outlined to the centralized email address.
We will use the migration process for all active CE certificates that do not have any ongoing associated work in progress.
For CE certificates undergoing changes or in the ‘work in progress’ category we will follow the pathways outlined below:
a. For projects in pre-certification recommendation or pre-certification decision making stage (Panel) we will migrate the existing certificate to the Netherlands NB before the end of March. We will move work in progress (WIP) to the NL NB to finish and issue an amended certificate from NB 2797. This action will alleviate the need to complete this work in BSI UK NB and subsequently complete the migration by 29 March.
b. For projects already at the UK NB 0086 that have already entered the certificate decision making process (Panel), these will be fully processed and certificates issued by UK NB 0086 and then migrated to NL NB 2797 within the required timelines.
Please be aware this effectively means we will no longer submit WIP related to CE certificates to the UK NB decision-making process Panel as of 31 January 2019 for manufacturers who wish to migrate certificates to the NL NB.
The UK NB will accept submissions for those clients wishing to place product on the UK market only. Thank you for the support, we assure you that our team are working tirelessly to ensure we maintain market access for our clients in this uncertain political time.
Where can I find more information?
For now, 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. Please check our Brexit web page for the latest information available and ongoing updates. If you have any questions or concerns, please contact your normal BSI contact at any time.
Clarification following the client communication above:
BSI agreed our migration process with both of our Competent Authorities (the UK and NL), we have now received clarity on the expectations regarding re-labelling of the migrated products. Relabelling must be completed within a reasonable timeframe.
A technical seminar for EU member states, in January 2019, confirmed that the re-labelling of individual products is not top-priority, as long as the key patient safety terms are met, e.g. Product has a certificate issued by an EU 27 NB, vigilance and surveillance are maintained, and there is full access to all documentation. As a manufacturer, you will need a labelling transition plan which will be assessed at BSI surveillance audits.
As of 29 March 2019 manufacturers based outside the EU need to have an EU Authorised Representative (EU AR) in one of the EU27 countries, who will fulfil all regulatory obligations of the applicable legislation. The three Medical Device Directives (AIMD/IVDD/MDD) require the name and address of the EU AR to be on the label or the IFU.
Manufacturers are required to have a transition plan, for updates to labels/IFUs, Technical Documentation and certificates as required. The manufacturer must ensure and demonstrate the traceability and continuity of communication for migrated products. The implementation of the plan will be assessed in BSI surveillance audits.
ISO 13485:2016 - The harmonized standard is here
BSI can now offer UKAS-accredited ISO 13485 certification to ISO 13485:2016 and to EN ISO 13485:2016. Talk to us to find out more.