The UK government announced a new bill aimed at the improvement of medical device regulations. It has already passed its first reading on February 11, 2020, and the second reading will take place on March 2, 2020.
Overview of the New Bill
The new Medicines and Medical Devices Bill covers human medicines, veterinary medicines and medical devices, describes the new regulatory approach and provides details regarding the interpretation and enforcement of the rules.
According to the Bill, the Secretary of State is entitled to amend or supplement the Medical Devices Regulations 2002. Any new amendments should be based on ensuring the safety of medical devices that are allowed to be marketed in the UK, maintaining a sufficient supply and availability of medical devices and creating a legal framework that would be attractive for companies that design or import medical devices.
In particular, the Secretary of State may make provisions related to the following:
- Requirements applicable to medical devices intended to be marketed in the UK, (e.g. requirements related to the development and producing of medical devices, their characteristics, and materials used), and the requirements applied to any parties involved in operations with medical devices (e.g. manufacturers, importers, suppliers);
- The procedures performed to assess compliance with applicable requirements;
- Entities eligible to perform the assessment of medical devices and issuing the appropriate certificates;
- Requirements regarding the appointment of the authorized representatives when it is necessary;
- Requirements regarding the declarations of conformity (DoC) made by the manufacturer;
- Requirements on packaging and labeling of medical devices, and on instructions for use and other informational materials supplied with the devices;
- Registers of medical devices, manufacturers and suppliers (e.g. the way such registers should be maintained, the information should be uploaded to the register, and access to such information);
- Clinical trials and other processes aimed at the collection of the data related to the clinical performance of medical devices;
- Post-market surveillance.
It is also indicated that the provisions regulating the aforementioned requirements could refer to the corresponding international agreements or standards.
The document also provides that the new regulations could set forth rules regarding fees payable by the parties involved, the information that can be disclosed and offenses connected with operations of medical devices. In particular, the new rules may address:
- All fees payable on all steps of a medical device’s lifecycle;
- The way the safety and performance information should be recorded and kept by the manufacturer and/or its authorized representative;
- The scope of the information that can be disclosed to state authorities;
- Amendments to the Medical Device Regulations 2002 in the part of offenses prescribed therein.
Another sphere the new provisions could cover relates to emergencies. In particular, they could set forth the rules applicable when it is reasonably necessary to implement additional measures to reduce the risk associated with the use of the device and the harm it could potentially or actually cause to a patients’ health. The appropriate requirements could be based on the regulations on medical devices or the protocols published by the Secretary of State, which is entitled to make changes to the protocols or withdraw them. Each protocol issued by the Secretary of State only remains in force during the particular period explicitly specified therein.
New Medical Device Regulations Enforcement and Notices
If the enforcement authority suspects that a particular entity or person operating with medical devices do not comply with the appropriate requirements, the authority is entitled to issue a compliance notice to:
- Indicate the particular provision the person fails to comply with,
- Describe in detail the reasons the authority suspects the noncompliance,
- Require restoring the compliance until the particular date specified therein,
- Require providing the evidence ensuring the compliance was restored,
- Require taking any additional measures necessary to comply with applicable requirements.
According to the Bill, the period indicated in the notice for the incompliant person to restore compliance should constitute at least 28 days from the day the notice was initially issued. It is also stated that the authority is allowed to make changes to the notice or revoke it if it would be found reasonable. Depending on the particular case, the compliance notice could be provided either directly to the manufacturer, or to its authorized representative in case if the manufacturer is a foreign entity, or to both of them.
Besides the compliance notice, the enforcement authority is entitled to issue another one type of notification – the suspension notices intended to impose restrictions on marketing the device in the UK in case of using such device is associated with hazards to patients’ health. In particular, the suspension notice could contain a requirement to suspend:
- Supplying the particular device,
- Its offering in the UK,
- Exposing it to be supplied or agreeing to supply it,
- Possessing such devices to supply them in the future.
The suspension notice should also contain the reasoning for the measures prescribed by the authority and a particular period the measures should be taken (this period should not exceed 6 months from the day the notice was initially issued). At the same time, depending on the particular case, the enforcement authority is also entitled to either reduce the prohibition period indicated in the notice or to revoke the notice at all.
In certain cases, the enforcement authority may also issue a safety notice. This type of notices is intended to restrict the availability of the particular medical device on the UK market due to safety concerns by imposing additional prohibitions or requirements regarding the same activities as indicated for the suspension notice. For instance, the person whom it concerns may be required to issue the supplementary warning to inform the patients and healthcare professionals about the risks associated with the use of the device and hazards it could cause or to arrange a recall of medical devices causing such hazards and explicitly specified in the notice. At the same time, the requirement to recall the device could be applied only in case if any other solutions would not be sufficient to protect patients’ health. Like the other types of notices, a safety notice should contain the reasoning for the actions required.
If the authority requires certain information the particular person engaged in operations with the medical device has, the authority could issue an information notice containing the requirement to:
- Disclose the information specified in the notice within the period of time indicated therein, or
- Issue records required by the authority and make them available for the person appointed by the authority.
The period indicated by the authority to provide the information should not be less than 28 days from the day the initial notice was issued.
Summarizing the information provided above, the new Medicines and Medical Devices Bill governs the powers of legislative and enforcement bodies and regulates the procedures related to notices the enforcement authority may issue in order to ensure the safety of medical devices available on the UK`s market and protect public health.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.