The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical device regulation, published guidance aimed to assist medical device manufacturers facing notified body withdrawals. According to the guidance, if a notified body working with a medical device manufacturer announces the withdrawal of its services, the manufacturer would be allowed to distribute its devices during an additional grace period before it would must conclude an agreement with another notified body.
Notified Body Withdrawal
Notified bodies are an entity designated under the appropriate regulatory framework to carry conformity assessment. Notified bodies were introduced to reduce the workload the national regulating authority faces all the time. The new system provides that notified bodies designated by the national regulating authorities should deal with the initial applications filed by the manufacturer and take all the measures necessary to ensure that any and all devices allowed to be placed on the market comply with applicable safety and performance requirements while the national regulating authorities would be able to focus on the improvement of the regulations and general market supervision and surveillance. To be designated as a notified body, an entity applying for designation must meet the eligibility criteria. For example, it should employ a sufficient number of qualified experts to be able to assess medical devices within the scope of designation. They should operate in a transparent, unbiased and independent manner. To place its medical device on the market, the manufacturer must conclude an agreement with a notified body that has the scope of designation necessary to assess devices of the type in question. At the same time, the scope of designation could be subject to substantial changes that could potentially affect the CE certificates issued previously by the notified body withdrawing its services.
UK Requirements for Notified Bodies in Detail
In accordance with applicable regulation, entities applying for the designation should pass an assessment audit to confirm the compliance with applicable requirements.
In particular, the notified body must:
- Provide the resources necessary to perform the conformity assessment,
- Be incorporated as an independent legal entity and provide the appropriate documents,
- Provide the information about all relationships (in a case when the entity applying for designation is a part of another entity),
- Have no connections with any particular manufacturer, supplier, or any other party involved in order to be unbiased and impartial,
- Not provide consultancy services to manufacturers,
- Implement an impartial remuneration system ensuring that the remuneration of the personnel does not depend on the particular results of their activities,
- Implement procedures preventing any external interference in the decision-making process,
- Confirm that the personnel has the experience and qualification necessary to perform safety and performance assessment for devices that fall within the scope of designation,
- Have the facilities necessary to perform examination activities,
- Implement all measures necessary to ensure the confidentiality of the information the notified body would be dealing with in the course of its activity, any of which could not be disclosed to any third party except the cases explicitly provided by applicable regulations,
- Arrange adequate insurance appropriate to the potential risks related to claims and litigations,
- Ensure that any subcontractors engaged in performing certain activities meet the requirements implemented by applicable regulations, and it is also strictly prohibited to subcontract the whole scope of procedures together with the responsibility,
- Duly document all the agreements with subcontractors, paying additional attention to the confidentiality issues,
- Notify the regulating authority on the engagement of subcontractors and provide detailed information about the scope of the relationship with each subcontractor,
- Keep the records reflecting all the procedures duly documented in accordance with applicable requirements,
- Ensure the implementation of quality system procedures.
After being designated, the notified body should be subject surveillance audits held on a regular basis. In case if it would be defined that the notified body fails to meet the appropriate criteria the authority is entitled to withdraw the designation. At the same time, the authority would provide the notified body with the possibility to make changes necessary to restore compliance prior to withdrawing the designation.
MHRA Grace Period
Existing legislation does not provide the regulation applicable in such cases to maintain the validity of the certificates. To solve this issue, the UK regulating authority issued present guidance introducing a special framework allowing medical device manufacturers to continue distributing their devices until they will conclude an agreement with another notified body that will maintain the validity of certificates in the future. The scope of the guidance covers both UK domestic medical device manufacturers and foreign manufacturers with their authorized representatives based in the UK who hold a valid certificate issued under the framework existing prior to the implementation of the Regulation 2017/745 (MDR) and Regulation 2017/746 (IVDR).
To be able to benefit from a grace period implemented by the document, the manufacturer shall fulfill a set of requirements including, among others, the following:
- Duly inform the authority on the current situation with arranging an agreement with another notified body,
- Notify the authority on the status of CE certification,
- Comply with all safety and performance requirements applicable to the particular medical device.
According to this framework, the MHRA would directly supervise the manufacturer and its devices during the whole grace period until a newly notified body would be found and it will take care of compliance assessment. Thus, the authority warns that if any evidence confirming the device’s failure to comply with applicable safety requirements would be identified, the permission would be withdrawn and the manufacturer would no longer be able to market its device in the UK. If the manufacturer passes a CE certification before the expiration date, the authority would suspend its direct supervision over the manufacturer and its devices.
At the same time, the authority additionally emphasizes that the described procedure “does not replace the activities of a notified body and it is not applicable to manufacturers who can’t transition their certificates from Directives 93/42/EC, 98/79/EC and 90/385/EC to Regulations 2017/745 [EU Medical Devices Regulation] and 2017/746 [In Vitro Diagnostic Regulation]”.
Each time the authority makes its decision whether to support a manufacturer or not depending on the particular circumstances.
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