F17.2. Please explain any other traceability requirements that should be introduced for economic operators. Q19.4 If you answered “yes” to question 19.3, please describe any specific requirements that should be introduced with respect to the application of UDI to medical devices, as well as any areas requiring clarification. Questions regarding registration requirements for health care facilities can be found in Chapter 3, Section 8. All organisations providing goods and services to an NHS trust will be affected by e-procurement requirements when implementing the programme. However, the NHS chose to apply e-procurement standards to the medical device industry first. On September 24, 2013, the United States Food and Drug Administration (FDA) published its final rule that device labelers must include a Unique Device Identifier (UDI) on most medical devices sold in the United States.1 The goal of the UDI system is to improve product safety by identifying a product throughout its journey. from manufacture to bedside use. UDI also improves supply chain monitoring and efficiency.
In recent years, other countries, regulatory groups, global purchasing organizations (GPOs), and integrated delivery networks (IDNs) have established similar UDI requirements, setting standards for accurate product data on device packaging and in electronic systems.2 While we follow industry trends and call the program “U.K. NHS eProcurement”, it is important to understand that each country in the UK has its own health authority. The current e-procurement requirements were introduced by NHS England and only apply to equipment organisations that do business with that authority. However, as England is by far the largest country in the UK, any organisation marketing medical devices in the UK is very likely to be affected by NHS eProcurement. It is also likely that the health services of Scotland, Wales and Northern Ireland will apply the same or similar requirements in the future. Similar to UDI requirements in the United States, e-procurement requirements will be phased in, with the highest risk classes of equipment coming first. The NHS introduced separate deadlines for the provision of product and price data, with product data needed first for each class, followed by price data for the same class a year later. As with UDI in the United States, the deadline for submitting data ends at the end of September each year. 21.7 The UK Medical Device Regulations could provide that the MHRA can ensure that information provided to it by medical device manufacturers and their UK Controllers (UKRP) and/or other economic operators listed in List One at the bottom of this section is published and made available to the public free of charge, subject to the relevant data protection requirements. This would mean that a member of the public could search the MHRA registry for detailed information about a medical device. If your organisation markets medical devices in the UK, you may have heard of the National Health Service (NHS) e-procurement programme.
Sometimes loosely referred to as the “UK UDI,” e-procurement shares some characteristics with the FDA`s UDI program, but is very different in many ways. In this article, we will give you a brief summary of the program and its requirements so that you can determine if your organization is likely to be affected. Q17.1 Do you think that the UK Medical Device Regulations should include the requirements for economic operators set out in paragraph 17.1 to ensure the traceability of medical devices? (`Yes` / `No` / `Don`t know/No opinion`) 19.20 The UK Medical Device Regulations could be amended to introduce rules for the UDI system to clarify the requirements of the regulation. For example, the rules could specify the circumstances under which a new UDI-DI should be assigned to a particular device, such as a change in the manufacturer`s trade name or a change in sterility of the device. 21.6 The UK Medical Devices Regulations may set deadlines during which the details of the registration of medical devices must be updated to include the additional information required. This could be introduced with different completion times depending on the class of medical device, similar to the registration requirements introduced earlier this year (detailed in the MHRA guidelines here). Q21.7 If you answered yes to question 21.6, please describe the information you wish to share, your reasoning and your main considerations or limitations (please note that information sharing is subject to the requirements of the UK GDPR). 19.12 The UK Medical Device Regulations could be amended to include requirements for the use of UDI and/or basic UDI-DI in certain circumstances, including: Q19.8 Do you think manufacturers should be required to assign and affix UDI to their medical devices before applying to approved bodies for conformity assessment? (`Yes` / `No` / `Don`t know / No opinion`). 19.11 The UK Medical Device Regulations could be amended to allow manufacturers to assign UDI to their medical devices before submitting an application for conformity assessment to an approved body (if necessary).
Name Address and contact details of the person(s) responsible for regulatory compliance b. an IUD production identifier (“UDI-PI”) that identifies the production unit of the medical devices and, if applicable, the packaged medical devices. The different types of UDI-PI include serial number, batch number, software identification, and date of manufacture or expiration date, or both. 18.2 Medical device manufacturers or their UK Responsible Persons (UKRP) are currently required to register all medical devices placed on the UK market with the MHRA in accordance with the grace periods provided for in the regulations (with some exceptions – see MHRA guidelines for details). 21.4 UK medical device legislation could be revised to expand the required information that manufacturers or their UK Responsible Person (UKRP) (if applicable) must provide to the MHRA before a medical device is placed on the UK market. You may be asked to provide the MHRA with the information listed in list one (at the end of this section). Status of the medical device (prior to placing on the market, placing on the market, non-placing on the market, recall, corrective safety action taken) e. when reporting serious incidents, e.g. the death of a patient, which may have been caused by the medical device (see Chapter 8, Section 47) to the AHRM (UDI-DI) – Liability of the economic operator preparing the report 21.10 UK legislation on medical devices could affect the economic operator commit you to confirm the accuracy of all data You have registered with the MHRA registration system no later than one year after the submission of information and every two years thereafter. Q19.14 Please describe the issuing bodies that should be designated by the MHRA. Please include the following information in your response: a. Should the MHRA designate one or more UDI clinics? b.
Should there be an issuing organization, which one (and why)? c. If there are several issuing organizations, which ones (and why)? (For IVDs) presence of tissues or cells of human origin or their derivatives (o/n). 21.5 Currently, only UK-based manufacturers or responsible persons in the UK are allowed to submit information to the MHRA registration database. In view of the additional information that may need to be submitted to the registration database (see section 21.4 above), the MHRA is considering allowing other parties to submit information such as non-UK manufacturers. 19.15 UDI issuing bodies operate UDI issuing systems. There are currently four designated issuers for the EU system: GS1, HIBCC, ICCBBA, IFA. For a future UK system, the MHRA could designate one or more issuing bodies. Manufacturers may be required to obtain a UDI from a distributor designated by the MHRA and apply it to the medical device before placing the device on the UK market. 21.8 UK Medical Device Regulations may include a requirement for manufacturers to register with the MHRA and submit the information listed one below before applying to an approved body for conformity assessment (if necessary). During the application process, manufacturers could be asked to provide their MHRA registration account number to the Approved Body so that the Approved Body can verify the registration of medical devices.
Section 26 of Chapter 6 contains proposals for recognised bodies to enter information on the status of the conformity assessment certificates they issue into the product registration system. Please read Chapter 6, Section 26 for comments. a. on the attestation of conformity (see Chapter 6, clause 26) for the medical device (UDI-Basic DI) – responsibility of the approved body 19.8 Manufacturers could also be required to use the basic UDI-DI as the main identifier for product models. The basic UDI-DI is used for administrative purposes to identify a group of devices with the same intended use, risk class and essential design and manufacturing characteristics. Essentially, a manufacturer can group similar types of medical devices under the same basic UDI-DI so that these groups can be recognized by others. The basic UDI-DI does not appear on the label or packaging of the medical device, but it would be included in regulatory documentation such as certificate of conformity, etc. Indicate whether the intended use of the medical device is not a medical purpose (for IVDs) Indicate whether the medical device is a “new” medical device Q19.10 Please describe any other circumstances in which the UDI-DI or basic UDI-DI is to be provided for a medical device.