EMA Guidance on Brexit
The EMA published several guidance documents dedicated to certain issues that medicine and medical device manufacturers may face due to Brexit. These documents provide, among others, the following clarifications:
- Impact on the regulation of substances as components of medical devices. Applicable legislation provides that if the device contains a substance that is a medicinal product, the device should be subject to the regulation under the appropriate medical device directive providing that the notified body performing the assessment of such device should be an applicant in communications with the medicines regulating authorities (EMA) regarding the medicinal product the device contains. In accordance with the regulations, to be entitled to act in a manner described, the notified body should be duly designated in any of the Member States, while the designation of all the UK-based notified bodies would be no longer valid due to Brexit. Thus, UK-based notified bodies would not be allowed to apply to the EMA for consultations and the authority would not be allowed to provide them with the opinion regarding the medicinal product subject to review.
- The validity of the certificates issued by the UK-based notified bodies. If the company holds a certificate issued by the notified body placed and designated in the UK before Brexit took place and intends to place the appropriate device on the EU market, it is necessary either to apply for a new certificate that would be issued by one of the EU-based notified bodies or to apply transfer procedures. In order to use a second approach described, it is necessary to conclude an agreement between three parties involved: the UK-based notified body which issued the initial certificate, the “new” EU-based notified body and the medical device manufacturer itself. Under such agreement, the certificate and all responsibilities associated with it would be transferred to the new notified body and the manufacturer would be able to communicate with it during all activities related to the medical device.
- Requirements for medical devices supplied together with the medicinal products. If the medicinal product is being supplied with the medical device as a separate product included in the pack, it is necessary to provide the confirmation of the medical device’s compliance with applicable regulations. In particular, the device should have a CE mark. According to the rules regulating the validity of the certificates, such CE mark should be approved by the new notified body, otherwise it would be necessary either to remove the device from the pack or to replace it with another device with a similar design and intended purpose that has a CE mark duly approved by any of the EU-based notified bodies after reviewing its dossier containing all necessary information to confirm the compliance with applicable safety requirements. At the same time, if medical devices form an integral product with the particular medicines, replacement or validation is not required since in accordance with applicable regulations devices of this type do not require a CE mark to be placed – thus, it is not required to make any changes to the dossier.
Apart from described above, the EMA provides other medicines-specific recommendations aimed to assist both medicines and medical device manufacturers in maintaining compliance with new regulations and requirements.
MHRA Notification on Brexit
According to the information provided by the MHRA via email, the EU regulations and rules related to medical devices would still be applicable in the UK during the transitional period. The email letters with the following information were dispatched to most of the companies operating with medical devices on the UK market and other parties involved. In particular, the authority informs that the notified bodies duly designated in the UK would remain entitled to perform conformity assessments of medical devices and to issue certificates allowing the applicants to place their devices on both markets.
The MHRA also noticed that it would continue to perform its obligations on reporting. During the whole transitional period, the agency must upload all appropriate information on adverse events to the online systems and databases it will still have access to in accordance with applicable rules and procedures. At the same time, the UK would no longer take part in any EU decision-making processes, which would lead to a certain decrease in the effectiveness of cooperation with EU bodies.
MHRA Amended Guidance On Medical Devices
The MHRA also amended the officially published information regarding Brexit and the way medical device manufacturers shall operate in order to place their devices on the UK market. First of all it is important to mention that the authority has withdrawn the no-deal Brexit guidance issued previously on January 3, 2019. The document was dedicated to certain aspects related to the medical device regulation in case of a no-deal Brexit, including the conformity assessment, requirements for the clinical investigations, rules on market surveillance and the way the new EU regulations (Medical Device Regulation 2017/745 and In Vitro Diagnostic medical device Regulation 2017/746) should be applied.
At the same time, the MHRA updates several guidance documents published previously to assist medical device manufacturers in compliance with applicable requirements and to provide them with additional clarification regarding the amended rules. For instance, the guidance on notified bodies was supplemented with an additional section regarding the withdrawal of notified body services describing in detail the solutions available in case if the scope of the designation of the notified body medical device manufacturer is working with would change significantly. Another important guidance updated by the authority is dedicated to clinical investigations of medical devices. It provides medical device manufacturers with additional information regarding the particular way clinical investigation in the UK should be designed, performed and reported, including the requirements to the documents to be submitted to the MHRA. The document also covers issues like adverse event reporting and the procedures applicable if it is necessary to suspend clinical investigation before the expected date.
Summarizing the information provided above, it is important to mention that medical device manufacturers should perform a set of steps in order to be allowed to market their devices both in the UK in the EU after the transitional period. Brexit will increase the regulatory burden on manufacturers since they would have to appoint additional representatives and pass conformity assessments for each of the markets separately.
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