Senior Manager, Regulatory Affairs, Medical Device & Diagnostic Research, ICON plc
On 10 January, 2018, the European Commission issued a Notice to Stakeholders entitled, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.”
The notice details the consequences of Brexit for United Kingdom (UK)-based economic operators and qualified third parties, known as notified bodies (NBs), associated with products that require a CE mark prior to being placed on the European market. These products include medical devices, active implantable medical devices and in vitro diagnostic medical devices.
As of 30 March, 2019 – the UK withdrawal date from the European Union (EU) – all EU primary and secondary laws will cease to apply to the UK, which will then become a “third country” if no mutual recognition agreement has been reached. When the withdrawal occurs, the following consequences will affect those companies involved in placing applicable products on the European market.
Importers and distributors
According to EU product legislation, an importer is an economic operator established in the EU who places a product from a third country on the EU market.
As of the withdrawal date, a manufacturer or importer established in the UK will no longer be considered an economic operator in the EU. Consequently, an economic operator established in the EU – prior to the withdrawal date – who was considered an EU distributor, will become an importer and will be required to comply with different obligations.
Authorised representatives established in the UK will not, as of the withdrawal date, be recognised as authorised representatives. Therefore, non-EU-based manufacturers, who are required to have an authorised representative established in the EU, are advised to take the necessary steps to ensure – as of the withdrawal date – that their designated authorised representative is established in the EU.
EU legislation on medical devices, active implantable medical devices and in vitro diagnostic medical devices requires the intervention of an NB in the conformity assessment procedure. EU product legislation requires NBs to be established in a Member State and be designated by a Member State notifying authority for performing the conformity assessment tasks set out in the relevant act of EU product legislation.
Therefore, as of the withdrawal date, UK NBs will lose their status as EU NBs and will be removed from the European Commission’s information system on notified organisations (NANDO database). As such, UK bodies will not be in a position to perform conformity assessment tasks pursuant to EU product legislation as of the withdrawal date.
Furthermore, as of the withdrawal date, a certificate issued by an EU NB will be required to place products on the EU market. Under the circumstances, manufacturers are advised to consider either applying for a new certificate issued by an EU NB or arranging for a file transfer, along with the corresponding certificate from the UK NB, to an EU NB who would then take over responsibility for that certificate.
There are currently five NBs located in the UK who are impacted by this announcement: BSI, LRQA, SGS UK Limited, AMTAC Certification Services Ltd (trading as Intertek), and UL International (UK) Ltd. While all are hoping that a withdrawal agreement will be put in place before 30 March, 2019, and are currently continuing with “business-as–usual,” they also are working on various contingency plans:
- BSI announced that it has formally applied for designation as a Medical Device NB in the Netherlands under EU Directives 90/385/EEC (Active Implantable Medical Devices), 93/42/EEC (Medical Devices) and 98/79/EC (IVD Medical Devices) within the oversight of the Dutch Health and Youth Care Inspectorate (IGJ).
- LRQA is taking contingency actions to obtain accreditation through other EU countries and is actively expanding those approvals it already holds in EU countries to replicate the appointments currently held in the UK. The majority of these new appointments will be in the Netherlands, with several applications – including the Medical Devices Directive and In Vitro Diagnostic Devices Directive – having already been submitted.
- SGS aims to retain its capability and capacity in the UK, but is working closely with the already established SGS NBs and other SGS European affiliates to ensure all customer certification requirements are met and that any necessary changes to processes are implemented as smoothly as possible.
- UL has been in discussions with the Health Protection Regulatory Agency (HPRA) in Ireland regarding the establishment of a medical device and IVD NB to support existing UL customers and to prepare for the transition. It hopes to make further announcements in the coming weeks with details of its future plans.
Further information, which is continually being updated, can be found on each of the NB websites.
ICON’s dedicated Medical Device and IVD regulatory and quality experts are available to help you understand these changes and how they impact your products. For assistance with any of the above items, or any aspects of medical device or IVD regulations, please contact us.