The Spanish Agency of Medicines and Medical Devices (AEMPS) announced the extension of the period provided for medical device manufacturers to implement changes to labeling required due to Brexit.
A General Overview of the Brexit Consequences
It is important to mention that the present situation is not the only one related to the possible no-deal Brexit. Earlier this year, in April, the Agency had posted a notice regarding changes in medical device regulations that would take effect in the case of the United Kingdom leaving the European Union (EU) without concluding an agreement and thus becoming a third country. The main points of the possible changes are the following:
- All medicinal products, including medical devices, originiating from the UK should be treated as if they were imported to the EU from a third country,
- Notified bodies operating in the UK will no longer be a party within the general EU legal framework. In other words, they will be unable to participate in the medical device registration process and all certificates and CE marking provided by these notified bodies would be no longer valid,
- All medical device manufacturers with their principal place of business in the UK will have to appoint their representative in one of the EU countries since all requirements to foreign manufacturers would be also applicable to UK manufacturers,
The notice also includes a set of rules regulating the distribution of medical devices. According to these rules, medical devices that are already present on the Spanish market, or already distributed in any of the EU countries (excluding the UK), could be also distributed in Spain in the future, and for such devices, the same requirements would be applied. At the same time, if such devices are already present only in the UK market, they would be subject to all regulatory procedures necessary to access the EU market.
The changes caused by Brexit would also impact the issues related to authorized representatives. For example, foreign manufacturers with representatives appointed in the UK would have to appoint representatives in one of the remaining EU countries and make appropriate changes to the certificates and other documents containing the information on the authorized representative.
Medical devices produced in the UK would be subject to the general importation procedure (except the devices already planned to be transported to the EU under the appropriate commercial agreements even if there was no physical delivery – in such case, it would have to be enough to prove existing arrangements without providing additional information).
Main Changes
The new requirements that medical device manufacturers will have to comply with also include new requirements on labeling, mostly surrounding the changes to the status of notified bodies. In particular, manufacturers with their medical devices already certified with the UK notified bodies would have to update their certificates since the certificates issued by the UK notified bodies would be no longer valid. To assist manufacturers in dealing with this issue, the Agency outlines three possible situations and provides the actions necessary to be taken in each of these scenarios:
- If the product has been manufactured and placed at the EU market (excluding the UK) before Brexit, there is no need to make any changes as long as the device complies with the certificates issued during the initial registration process,
- If the device was manufactured before Brexit but was meant to be placed on the market post-Brexit, additional changes would be needed. A manufacturer would have to engage new notified body that would be responsible for the particular medical device in the future. Certificates should also contain information on both previous and new notified bodies while the identification number of the notified body should remain the same.
- If the product was scheduled to be manufactured after Brexit, it would have to bear the number of the new notified body.
Additional recommendations of the Agency
To maintain compliance with applicable regulations, the Agency advice medical device manufacturers to perform several important steps, including, among others, the following:
- If the business of the company requires the transfer of medical devices from the UK, it is necessary to obtain an appropriate importation license issued by the Agency.
- Manufacturers already distributing their devices in Spain should update the certificates and make necessary changes to the labeling and instructions (associated with the change of notified bodies). This is the exact requirement the application of which, under the notice published recently by the Agency, would be rescheduled to June 30, 2019.
- Changes to labeling should also reflect the appointment of the new authorized representative. According to the applicable regulations, labeling should include the information about an authorized representative appointed by the manufacturer in one of the EU countries to be responsible for all communications regarding the device.
- Manufacturers with their devices supervised by the UK authorities would have to transfer the existing certificates or to obtain new ones.
The Agency also announced that manufacturers must prepare the documentation on all their medical devices at all stages of the process. This documentation should contain information on all devices being provided to the distributors or currently on their way, including the particular lot and serial numbers identifying the particular device.
According to the information available to the Agency, some of the medical device manufacturers have already performed all changes needed while some of them just initiated the transition process. At the same time, the Agency decided to extend the period provided to manufacturers to regain compliance with new regulations since some of the manufacturers may find this process complicated or difficult. The announced extension would give medical device manufacturers more time to implement all changes to the labeling of their medicinal products.
It is also important to notice that despite the relief introduced by the Spanish medical device regulating authority, the requirements similar to the ones described above would also be applicable in other remaining EU countries while the relief would be in force exclusively in Spain. That is why medical device manufacturers intended to market their products not only in Spain but in other EU countries too would have to comply with such requirements within the standard terms.
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