The new article describes in detail various specific aspects related to the regulatory requirements that in vitro diagnostic medical devices are subject to.
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The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority, has published a guidance document dedicated to the regulatory status of in vitro diagnostic (IVD) medical devices. The document provides an overview of the regulatory requirements set forth under the existing legal framework, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
The provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance, should such changes be reasonably necessary to reflect corresponding changes to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the conformity assessment process IVD medical devices should undergo in order to ensure their compliance with the applicable regulatory requirements in terms of safety and efficiency when used for their intended purpose.
UKCA Marking and Related Procedures
As explained in the guidance, medical device manufacturers have the option to use the UKCA mark up until June 30, 2030. During this period, CE-marked medical devices will still be accepted in the Great Britain market. The exact timeframe for such acceptance should be determined based on the device type and the legislation it is subject to, with the latest date being June 30, 2030. Devices initially intended for performance evaluation are exempt from UKCA marking requirements.
According to the document, in order to affix the UKCA mark, medical device manufacturers must ensure compliance with the provisions of the UK MDR 2002. The presence of this mark demonstrates the manufacturer’s assurance that the product complies with all necessary regulations, including safety standards. Devices with the UKCA mark can be placed on the market in Great Britain, which includes England, Wales, and Scotland.
However, the mark is not recognized in the EU, EEA, or Northern Ireland. In contrast, devices intended for the EU, EEA, or Northern Ireland must still have the CE marking. A separate CE UKNI mark is available for devices in Northern Ireland, but these cannot be marketed in the EU or EEA markets.
Regarding the technical process of affixing the UKCA marking, the authority explains that it should be visibly and clearly placed on the device, its instructions for use, and the commercial packaging. If an approved UK body has been involved, its number should be indicated next to the UKCA marking.
It is also important to mention that IVDs that are not on the market but are used professionally still fall under conformity assessment procedures. For instance, a diagnostic service provider might manufacture an IVD for internal use, such as their own reagents, without placing that device on the market. In such cases, the appropriate conformity assessment procedure should be followed.
Additional Regulatory Requirements
The scope of the guidance also covers additional regulatory requirements that IVD products should meet in order to be allowed for marketing and use in the country. The guidelines and regulations for in vitro diagnostic devices issued in the UK cover a wide range of aspects, from the language used on labels to post-market surveillance procedures.
For instance, the MHRA explains that labeling is a vitally important element in the regulation of IVDs. According to Regulation 35(2), labeling for every device, as well as instructions accompanying it should be provided in English. This ensures that both medical professionals and consumers have clear and understandable information, reducing any potential misinterpretations or mishandlings that could arise due to language barriers.
The process of registration is another area rigorously regulated in the UK. Regulation 44 explicitly states that any manufacturer with a business registered in the UK must formally register their device with the MHRA prior to launching it in the Great Britain market. The scope of products subject to registration requirements is not limited to just the medical devices intended for sale but extends to those made available for performance evaluations as well. If the device is placed on the market on behalf of a manufacturer having no registered business place in the UK, it still requires registration with the MHRA before any market placement.
In accordance with the applicable legislation, in the case of medical device manufacturers placed abroad, the appointment of a UK responsible person will be required. They bear various responsibilities, including ensuring the correct drafting of the declaration of conformity and technical documentation. They are also responsible for communication between the MHRA and the medical device manufacturer, making sure that any necessary documents are made available upon request, and aligning on corrective actions if there are issues with the device. Furthermore, the UK Responsible Person plays an active role in maintaining open communication channels with the MHRA when it comes to the safety and efficacy of devices and manages complaints and reports on the device’s performance.
As further explained by the MHRA, post-market requirements are quite strict and detailed as well. Medical device manufacturers are obliged to establish a “vigilance system: which is essentially a framework to notify the MHRA about any incidents associated with the device that could or have led to serious health consequences or necessitate the recall of a device placed on the market. In such a way, post-market surveillance ensures that even after an IVD device has been approved and is in use, it remains under scrutiny to ensure its safety and effectiveness when used for its intended purpose.
It is also important to mention that, apart from the IVD-specific regulations described herein, medical device manufacturers should ensure compliance with other laws and regulations their products are subject to. For instance, the Health and Safety at Work Act 1974 prescribes that any product should be safe and should not possess health risks. The said act emphasizes the importance of proper testing and examination that the products should undergo. In addition to this, all products containing radioactive substances should comply with the Radioactive Material (Road Transport) Regulations 2002.
In summary, the present MHRA guidance provides an overview of the regulatory requirements applicable to in vitro diagnostic medical devices intended to be marketed and used in the country. The document highlights specific aspects to be taken into consideration by medical device manufacturers in order to ensure compliance with the existing legal framework and explains the most important regulatory requirements and concepts.
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