The MHRA and other UK healthcare authorities and associations of manufacturers and suppliers are actively preparing to deal with issues regarding medical devices and medical product supply arising in the case of a no-deal Brexit.
Guidance on Medical Products Supply
The United Kingdom’s Secretary of State for Health and Social Care, who is responsible for oversight of National Healthcare Service, issued guidance for healthcare industry representatives describing the possible outcomes of a no-deal Brexit and its potential impact on the supply of medical products. One issue that may arise is that in the case of a no-deal Brexit, the importers of medical devices will have to deal with new customs procedures that could lead to delays in the supply. That is why all parties involved should take measures necessary to prevent such delays and to maintain the supply of important medical products to healthcare institutions and patients in a timely manner. It was announced that the Government will establish a special unit intended to assist suppliers in dealing with any issues that arise. This unit will be composed of specialists providing consultations and guidance on the measures to be taken in the course of preparation. Each medical product supplier or distributor will be able to contact this support unit to obtain advice and assistance on any step of the procedure. Medical device suppliers are also invited to register to access the freight capacity, in the course of procurement for securing freight capacity established earlier. The main goal of the process is to conclude contracts with freight operators to make sure supplies are maintained without interruption. The Government announced that eight companies had already been appointed within the freight procurement framework. It was also stated that some extraordinary legislative measures could be taken in case if it would be necessary due to the actual situation with the supply and the availability of medical products.
At the same time, representatives of the UK Bioindustry Association, a trade association and a global hub for companies involved in innovative life sciences research, uniting research centers, biotechnology, pharmaceutical and technology companies, and start-ups, advise medical device manufacturers to analyze the demand on products and to participate in supply route procuring programs. The representatives referenced to the report, issued by the National Audit Office, stating that the flow of goods could be reduced up to 60%, but would restore back only after approximately 12 months.
Update from MHRA
The healthcare regulating authority in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA), has issued the new guidance describing how to prepare for new requirements applicable in the case of a no-deal Brexit. The authority also updated its guidance on regulating medical devices issued earlier by supplementing it with the recommendation for all parties involved in medical device manufacturing, importation and distribution to be prepared for no-deal Brexit on October 31, 2019. In particular, the guidance describes the regulations applicable to medical devices and the way they should be applied after the Brexit. The UK Medical Devices Regulations 2019 (UK MDR 2019), as a part of national legislation, would regulate all appropriate aspects. It will be based on the same principles as EU MDR and EU IVDR. The UK MDR 2019 will be implemented later. Till that time, the EU Directives (Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive) will still be applicable through the UK MDR 2002.
Additionally, the MHRA states it is also important to provide details on the legal status and responsibilities of the UK Responsible Person introduced in the recent amendments to the UK MDR. This Responsible Person should be established in the UK and represent a foreign medical device manufacturer before the regulating authority. At the same time, manufacturers may appoint one or several representatives. To appoint a UK Responsible Person, the manufacturer shall issue a letter of designation or to conclude a contract regulating all aspects of carrying on the representative functions. Both individuals and legal entities could be appointed as a UK Responsible Person. At the same time, anyone going to place the device on the market should receive the approval of the manufacturer – in other words, to be designated. Main responsibilities of the UK Responsible Person include keeping documents related to the medical device and providing them to the MHRA on demand of the authority, informing the manufacturer on all issues occurring when using the device and also the scope of responsibilities related to the registration procedures, including ensuring the performance of all necessary trials and examinations.
Actions Manufacturers Should Take
The first thing medical device manufacturers must do is register with the MHRA. According to the applicable regulations, medical device manufacturers based outside the UK shall appoint UK Responsible Person as a representative in the UK to perform the registration process on their behalf. At the same time, Authorized Representatives designated before would no longer be able to perform their functions. After this, it will be necessary to check the classification of the medical device in question in accordance with the new classification requirements. Generally, to be allowed fto be placed on the UK market, medical devices should meet safety, performance and labeling requirements, new clinical evidence requirements that were updated and schedule annual periodic safety reports.
UK Responsible Persons must carry out important responsibilities, namely:
- to keep copies of all documents related to medical devices and provide them on demand of the regulating authority,
- to ensure compliance with applicable regulations and requirements,
- to inform the manufacturer on all issues arising when using the device by patients or healthcare professionals,
- to transmit all requests to the manufacturer,
- to conduct actions intended on the implementation of corrective actions taken by the manufacturer and in other ways provide the assistance necessary to mitigate the risk associated with the device,
- to suspend providing the representative functions and to terminate the agreement in case of substantial violation of the applicable regulations by the manufacturer.
Medical device importers will have to comply with a set of new requirements. They should duly inform customers about the risks associated with the device and provide them with all the information needed to maintain the safety and efficiency of the device. They will also have to perform continuous monitoring of any issues related to the safety of the device that may arise during the use. In such case, they will have to inform manufacturer on such events, provide them with all information related to such issues and also assist them in taking safety measures including Field Safety Corrective Actions – special actions conducted by the manufacturer to prevent and reduce the harm caused to patients as a result of using a faulty device. Such measures could include providing additional instructions or even withdrawal or replacement of the medical device if the risk is substantial enough. The medical device manufacturer is also obliged to inform MHRA on all Field Safety Corrective Actions performed, the reasons for such actions, the scope of devices subject to such actions, and the consequences associated. The labeling of medical devices should also contain the name of the manufacturer, the information on the importer and local representative (if applicable), CE-marking and a Unique Device Identifier (UDI) assigned to the device and used to track the device and to confirm its origin.
How RegDesk Can Help
RegDesk platform provides medical device manufacturers with the information on the most important changes in the regulations and requirements to medical devices to simplify compliance with the applicable legislation. No-deal Brexit could lead to substantial changes in the regulation of medical devices in the UK, so all manufacturers interested in placing their devices on the UK market should be aware of upcoming changes to be able to perform proper preparations.