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Brexit impact in relation to Medical Device Directives

We are committed to providing our clients continuity of service regardless of the outcome of the negotiation process and are taking all necessary actions to ensure this.

The UK and EU have yet to finalise the agreement for the UK to withdraw from the EU. Through our involvement in Standards Committees, Notified Body Forums and strong relationships with government and industry, we are closely involved with developments.

We will make it as easy as possible for our clients to maintain their Notified Body (NoBo) approvals, ensuring that they retain their access to EU and UK markets.

As negotiations progress, we will keep you updated both on this page and via our account managers and business support teams.

Our status as an EU NoBo is particularly relevant to our assurance and inspection work performed under various EU Directives and Regulations and to our services including Medical Directives. Although Brexit negotiations could result in arrangements under which the UK continues to operate its own NoBos, we are actively preparing for the possibility that UK NoBos will lose their current status from March 2019, as both the EU Commission and HM Government have indicated in their respective statements around the impact of a “hard Brexit”.

We are firmly committed to remaining a major EU Medical Device NoBo and have developed several options for how this will be achieved dependent on the final agreements made between the EU and UK. We already hold NoBo status in several major EU27 countries and are expanding these approvals to replicate the appointments we hold in the UK.

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 is unaffected by Brexit.

We will continue to provide updates as events unfold.

Frequently asked questions

  • Will Lloyd's Register continue to provide Notified Body services in the EU after Brexit?

    We have also made applications for ATEX, CPR, MD, MED, ND, PPE, PED and the SPVD directives to RvA in the Netherlands for NoBo approval for Lloyd's Register Verification BV.  We already hold a variety of accreditations in the Netherlands through which we have a longstanding relationship with RvA.

    The applications are in various stages of assessment, with an expectation of obtaining approvals starting from around the end of 2018.

  • How long will my existing Lloyd's Register certificates remain valid for?

    Unless a mutual recognition arrnagement is agreed between the EU and the UK either on a transitional or permanent basis as part of the Withdrawal Agreement, currently issued LR certificates will cease to be valid with effect from the withdrawal date (30 March 2019 00:00 hrs CET). There are indications that mutual recognition of Notified Bodies will be included within the scope of 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. However, to address the possibility that there could ultimately be no recognition agreement between the EU and the UK, we are taking all necessary measures to enable us to continue to support our clients, by obtaining Notified Body appointments within the EU27. 

  • What steps do I need to take now to transfer certificates that will continue to be recognised by the EU?

    As we are in the process of taking all the necessary action to mitigate against the potential outcomes our clients do not currently have to take any further action. Whilst the outcome of EU and UK negotiations is unknown, we remain committed to making the transfer of certificates as simple as possible for all our clients. 

  • How much will it cost to get new certificates?

    We appreciate that the UK’s decision to leave the EU may result in additional costs for our clients and for ourselves. It is our intention to work with each client individually to determine an appropriate transfer strategy and, wherever possible, we will seek to absorb all reasonable costs, e.g. the costs of reissuing certificates. 

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