With the anticipated departure of the United Kingdom from the EU, medical device manufacturers are exploring whether it will be possible to continue to export devices that mention a UK notified body or UK authorised representative on their label to the other EU Member States after 31 October 2019 (the scheduled date for Brexit).
A number of EU Member States have developed related derogation procedures for manufacturers of medical devices. Moreover, the Notified Body Operations Group (NBOG) has provided guidance concerning change of notified body. The guidance provides that, in the case of an "enforced" change of notified body, competent authorities may allow manufacturers to place or keep medical devices with the identification number of the previous notified body on the market in their territory for a certain time.
This reviews the derogation procedures established in a number of EU Member States.
2. The Dutch derogation procedures
2.1 Derogation concerning a UK notified body
The first derogation procedure applies to manufacturers who have not yet transferred to a notified body in one of the remaining 27 EU Member States. An exemption procedure has been established for medical devices and in vitro diagnostics. The procedure applies, however, only for reasons of continuity of supply.
To qualify for the exemption applicants must demonstrate that:
- application for a new CE Certificate of Conformity has been requested from a notified body in one of the 27 EU Member States before the Brexit date; and
- the medical device or in vitro diagnostic will be delivered only to Dutch healthcare providers who already have purchasing arrangements in place in relation to the products.
The derogation is based on Article 8 of the Dutch Law on Medical Devices. This Article provides the Minister of Health with the power to grant exemption from obligations for which the Law provides. The exemption will be valid until a notified body in one of the 27 EU Member States has issued a CE Certificate of Conformity for the medical device or until the date indicated in the derogation. The Dutch authority may impose further conditions and limitations concerning the derogation.
The exemption procedure will be applied on a case-by-case basis. Moreover, all related conditions must be met before the exemption will be granted.
2.2 Derogation concerning labelling
A second derogation is available where, although the manufacturer has completed the transfer to an EU notified body, the labelling of the medical device does not yet reflect this transfer. This can be either because, the label still mentions a UK notified body or, the label still mentions a UK authorised representative.
Where transfer to a notified body in one of the 27 EU Member States has taken place and the notified body has found a medical device to be safe, a "tolerance" construction will apply for the labelling. This means that during a period of six months after the Brexit date, the Dutch authorities will not undertake enforcement activities related to the labelling for failure to reference the new notified body.
In order for the derogation procedure to be available a request must have been submitted to a Notified Body in one of the 27 EU Member States before the Brexit date. The manufacturer should also agree that information relating to the CE Certificate of Conformity that has been issued by the new notified body and the related medical devices may be published on the website of either the Dutch Health Care Inspectorate or Farmatec. If an extension to the derogation is necessary after the six month period, manufacturers should submit a substantiated request for an extension to the existing derogation to the Dutch Ministry of Health and the Health Care Inspectorate. The request must be supported by a reasoned approval by the responsible notified body.
3. The position in other EU Member States
The Austrian competent authority for medical devices' (BASG) guidance on Brexit does not include guidance concerning Brexit and orphaned manufacturers. We understand, however, that BASG will follow the guidance concerning orphaned manufacturers provided in the NBOG Best Practices Guide. This means that BASG would examine applications from orphaned manufacturers on a case-by-case basis. BASG may decide, on a temporary basis, not to enforce the legal requirements resulting from the absence of a valid CE Certificate of Conformity for a medical device issued by an EU notified body.
We understand that the Belgian competent authority, the Federal Agency for medicines and health products (AFMPS), has not developed a derogation procedure. A case-by-case derogation could, however, be granted by the Agency to manufacturers. The contact email address for requesting a derogation is [email protected].
The AFMPS publishes any guidance related to Brexit here and may update the guidance in the future.
The French National Agency for the Safety of Medicine and Health Products (ANSM) has established two derogation procedures.
- The first procedure is not Brexit-specific and concerns medical device manufacturers orphaned as a result of de-notification or a cessation of activities of a notified body. The notified body does not need to be established in the UK. This procedure was established in 2016 and updated in June 2019. It is based on an information bulletin/QA issued by the ANSM. An application with supporting documentation must be sent to the ANSM by email to the following address [email protected]. More details are available on the ANSM website.
- The second procedure is available only where a risk exists of supply disruptions of a regulatory nature due to Brexit. This could, for example, occur where a CE Certificate of Conformity has been issued by a notified body located in the UK. The purpose of the procedure is to ensure continuity of care in this context. This procedure was established in February 2019 by a letter sent by the ANSM to manufacturers. Manufacturers who anticipate delays and supply difficulties of a regulatory nature must inform the ANSM as soon as possible by sending an email to [email protected] to request derogation. The email must include:
- elements demonstrating that the medical device(s) concerned by the potential delay or supply difficulties are essential to the continuation of care; and
- a timetable showing the steps planned by the manufacturer in order to regularize the situation.
The German competent authority, the Federal Institute for Drugs and Medical Devices (BfArM), has published guidance concerning medical devices and Brexit on its website.
We understand that no German legislation has yet been adopted to establish derogation procedures. German authorities are awaiting the outcome of discussions between EU Member State competent authorities.
Each regional (Land) German competent authority has discretion concerning how to address orphaned manufactures. The local competent authority must be informed by the manufacturer that the manufacturer has been orphaned. After being notified, the local competent authority may take an informal decision not to enforce related laws on a temporary basis.
The Greek National Organization for Medicines (EOF) has not published any updates concerning Brexit. We understand that EOF does not currently have a derogation procedure for medical devices manufacturers in relation to Brexit in place. Should a derogation procedure be established in the future the EOF would handle any related requests from manufacturers on a case-by-case basis.
The Health Products Regulatory Authority (HPRA) website has a dedicated section concerning the impact of Brexit impact on medical devices. This includes preparation for a no-deal Brexit. HPRA does not currently have derogation procedures for orphan manufacturers. We understand that any requests from orphaned manufacturers would be treated on a case-by-case basis.
We understand that no derogation procedures have been established by the Italian authorities thus far.
We understand that a case-by-case derogation procedure is available to orphaned manufacturers provided the following conditions are met:
- The manufacturer or their authorised representative established in one of the 27 EU Member States holds a CE Certificate of Conformity issued by a UK notified body that could not yet be transferred to a notified body established in one of the 27 EU Member States;
- The individual medical device(s) is of critical importance for the protection of health;
- There is a lack of suitable substitutes available;
- The derogation sought is temporary and the period of validity would, in principle, not go beyond 31 December 2019.
To permit the competent authorities to assess whether the conditions set out above are met, the affected manufacturer must provide justification concerning why it was unable to transfer to a notified body established in one of the 27 EU Member States prior to the withdrawal of the United Kingdom, and demonstrate the criticality of the medical device.
The contact email address for requesting derogations is: [email protected].
Derogation rules concerning orphaned manufacturers result from the Polish Medical Devices Act. These general derogation rules, which apply to all manufacturers, include the possibility of an additional period of validity of CE Certificates of Conformity issued by UK notified bodies. The related agreement of a new notified body based in one of the 27 EU Member States is, however, necessary. The interpretation of these rules with respect to Brexit was made by the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in an official communique.
On 1 March 2019, the President issued a statement providing that under the derogation rules provided in the Polish Medical Devices Act, a derogation from labelling rules would be made regarding CE Certificates of Conformity issued by a UK-based notified body.
These Certificates could remain valid 12 months after Brexit provided they were supported by a written confirmation from the new EU notified body that it would assume direct responsibility for the devices covered by the UK Certificates and that it would undertake to re-certify these products within these 12 months.
The statement also provides that no specific rules concerning labelling of medical device after Brexit would be issued.
We understand that no derogation procedures have been established in Spain.