The new article highlights aspects related to the in-house manufacture of in vitro diagnostic medical devices.
Table of Contents
The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the regulatory status of in vitro diagnostic (IVD) medical devices intended to be marketed and used in Great Britain. The document provides an overview of the applicable regulatory requirements, 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 therewith.
At the same time, provisions of the guidance are non-binding in their legal nature, and they are not intended to introduce new rules or impose new obligations. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
According to the guidance, the UK MDR 2002 (Medical Device Regulation) has specific implications for devices manufactured and used by health institutions for their own patients, known as “in-house manufacture”. This document mainly focuses on the in-house manufacture of in vitro diagnostics, even though it should be read alongside general guidance available on the MHRA website.
Regulatory Background
The UK MDR 2002 is applicable not only to devices sold on the market but also to those put into service and used professionally. It covers, inter alia, test kits used by commercial testing service providers in-house but not placed on the market. However, Regulation 33 exempts health institutions from these requirements under certain conditions. The exemption is explicitly applicable for products manufactured and used within the same health institution without transferring ownership to a different legal entity.
Definition of Health Institution
As explained by the MHRA, a “health institution” is primarily concerned with the care and/or promotion of public health. Organizations such as NHS trusts and the National Blood Authority fall within the said definition. Private healthcare providers also fit this category, provided their primary focus remains public health. However, entities such as stand-alone diagnostic laboratories or establishments focused solely on providing diagnostic services do not qualify and, consequently, would not be able to benefit from the exemption described hereabove. Furthermore, the authority mentions that wellness and fitness centers (e.g., gyms and spas) are also excluded.
Criteria for Exemption
In order to assist the parties involved, the authority further describes specific criteria to be applied when determining eligibility for the exemption. According to the guidance, the exemption applies in two situations, namely:
- The device is manufactured and used within the same health institution in the premises controlled by the same entity.
- The device is manufactured and used within the same health institution on premises in the respective use environment, provided it hasn’t been transferred to another legal entity.
Examples
The guidance also provides several examples illustrating the way the approach described in the document should be applied.
- Example 1: An NHS trust hospital manufacturing an IVD in-house for use either within its premises or a related location will be exempt from the aforementioned requirements, provided the usage is associated with its healthcare functions.
- Example 2: If a health institution manufactures an IVD but uses it in a different part of the institution not in the respective use environment, the exemption does not apply.
- Example 3: When a device is transferred to a different legal entity, even if it’s on the same premises, the exemption usually does not apply. There could be exceptions if two different legal entities can be treated as a single health institution under specific circumstances.
- Example 4: If the device is transferred to another legal entity on nearby premises, the exemption still does not apply.
Thus, the transfer of ownership is one of the most important criteria to be applied when determining eligibility for the exemption from the regulatory requirements described herein.
Modifications and Regulatory Requirements
The MHRA further explains that if a device is modified to the extent it can be considered a new product, it will fall under the scope of UK MDR 2002, unless the health institution exemption is applicable. There is no pre-defined rule describing when a modified device becomes a “new” device; each time, the appropriate decision should be taken on a case-by-case basis, primarily focusing on the importance of changes introduced and the extent to which these changes are expected to affect the safety and performance of the device in question.
In summary, the authority explains that health institutions must consider multiple factors, such as the definition of a “health institution”, the premises where a device is used, and whether it has been transferred to another legal entity, when determining whether they are eligible for an exemption from the UK MDR 2002 regulations. Understanding these conditions is vitally important for ensuring compliance with the applicable regulatory requirements and also for being able to benefit from any applicable exemptions.
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