Brexit - Information for the professional

The FAMHP wants to support health care providers, the pharmaceutical industry and the medical devices industry before and after Brexit. Preventing any shortages of medical devices for the patient is central to this.

In this section, you will find various information about the impact of Brexit and the possible measures that must be taken. We will update this information regularly as the situation evolves.

 

News

Medication FAQ
Information for promoters

Specific information for sponsors of clinical trials

(1) Will an authorized representative in the UK still be valid?

(2) Does something have to be changed before the batch release of Investigational Medicinal Products (IMPs)?

(3) Are there specific regulations for the submission of substantial amendments?

 

(1) Will an authorized representative in the UK still be valid?
Without a withdrawal agreement after Brexit, the United Kingdom (UK) will be considered a third-party country. Thus an authorized representative in another European member state (EU 27) will be required for all clinical trials with a sponsor from the UK. Authorized representatives in the UK for non-EU sponsors will also no longer be valid. Before the UK leaves the EU, the authorized representative must be changed via a substantial amendment whereby section B2 of the European application form is amended.

(2) Does something have to be changed before the batch release of Investigational Medicinal Products (IMPs)?
After Brexit, the batch release of IMPs produced in the UK will no longer be insured by the qualified person of an importer located in the UK. The batch release must be done by the qualified person of an importer located in another European member state. The same applies to IMPs produced outside of the EU. Before the UK leaves the EU, the importer and qualified person must be changed via a substantial amendment whereby section D.9.2 of the European application form is revised, with a new QP declaration and a manufacturing authorization of the new importer and a revision of the section “manufacturers of the drug product” of the investigational medicinal product dossier (IMPD).

(3) Are there specific regulations for the submission of substantial amendments?
A substantial amendment can be submitted for different clinical trials. The retribution or “fee” for a substantial amendment must be paid for each clinical trial. We also advise grouping per IMP as much as possible for the submission of the amendments.

 

Specific information about medical devices for professionals, hospitals and the industry

Information for hospitals

(1) Which medical devices will be affected by Brexit?
(2) What are the consequences if a medical device is affected by Brexit?
(3) How do I know if a medical device is legally sold AFTER Brexit?
(4) What does “to bring to market” mean?

 

(1) Which medical devices will be affected by Brexit?

Check the information on the medical device’s package. A device will be affected by Brexit if one or more of the following criteria are met:

  • the manufacturer is headquartered in the United Kingdom;
  • the authorized representative is headquartered in the United Kingdom;
  • the CE mark is followed by one of the following numbers: 0086, 0088, 0120, 0843.

(2) What are the consequences if a medical device is affected by Brexit?

If the medical device affected by Brexit was sold legally in Europe BEFORE Brexit, it may circulate freely within the territory of the 27 EU member states (EU27).

If the medical device affected by Brexit is sold in Europe AFTER Brexit, the manufacturer must make a number of revisions to be able to sell the device on the European market.

  • Manufacturers who are based in the United Kingdom must be represented by an authorized representative present in the EU27.
  • Manufacturers with an authorized representative in the United Kingdom must appoint a new authorized representative within the EU27.
  • For CE certificates issued by a British-registered institution (numbers 0086, 0088, 0120, 0843), a new CE certificate must be requested and recognized by a registered institution headquartered within the EU27.

The FAMHP is working closely with the affected parties to find a solution for all medical devices that may encounter problems after Brexit. Considering the unsure outcome of Brexit and the large number of medical devices impacted, the FAMHP is advising hospitals to take the following actions:

  • Contact the manufacturer or distributor to ask whether the necessary measures have been taken for the transfer of the CE certificate and/or designation of the authorized representative within the EU27.
  • Contact the distributor of the product to ensure that they have sufficient inventory to cover the first months after Brexit, which will probably be the most critical period.
  • Research possible alternatives not affected by Brexit.
  • If necessary, you can build up a larger inventory yourself.

(3) How do I know if a medical device is legally sold AFTER Brexit?
In order to legally operate after Brexit, the manufacturer of the medical device must be located in the EU27 or have an authorized representative in the EU27. The medical device itself must have a CE certificate originating from an institution registered in the EU27, if it must have a CE certificate to bring to market in the EU.

(4) What does “to bring to market” mean?

To bring to market is making the device available to another entity for the first time by the manufacturer. This means that it is the first change of ownership. This may be a transaction against payment or a free transaction between the manufacturer and a distributor. (Royal decree of 18 March 1999 concerning medical devices article 1 §2 8°)

 

Information for manufacturers and distributors

 

Manufacturers of medical devices must check whether their products are certified by a British-registered institution (BSI (0086), Lloyd’s Register Quality Assurance Ltd (0088), SGS UK (0120) and UL International (0843)). If this is the case, the manufacturer must have the products certified by another registered institution headquartered in a European member state (EU27) before Brexit.

Manufacturers of medical devices outside of the EU27 must designate an authorized representative within the EU27 to launch their medical devices on the European market. The FAMHP has developed a decision tree to help manufacturers take the right actions.

Last updated on 13/09/2019