The new article addresses the aspects related to the conformity assessment procedures in vitro diagnostic medical devices should undergo in order to ensure their safety and proper performance.
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 in vitro diagnostic (IVD) medical devices and the regulatory status thereof. In particular, the document provides an overview of the applicable regulatory requirements, as well as additional clarifications to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto.
At the same time, 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 amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the conformity assessment IVD products should undergo in order to ensure safety and proper performance, as well as compliance with any and all applicable regulatory requirements such products are subject to in accordance with the existing legal framework.
Conformity Assessment Process: Key Points
As explained by the authority, the parties responsible for IVD devices (medical device manufacturers), before placing their product on the market, should:
- Assign their devices to one of the relevant risk categories;
- Ensure that the device meets the “essential requirements”;
- Follow the appropriate conformity assessment procedure;
- If appropriate (depending on the risk category of the device), ensure that an independent certification body (called a “UK approved body”) is involved in the conformity assessment procedure.
As it was mentioned before, in vitro diagnostic medical devices intended to be used in the UK in line with the professional activity of the manufacturer should also undergo the appropriate conformity assessment, even though they are not intended to be marketed in the country.
Terms and Definitions
The document further provides definitions of the most important terms and concepts used in the context of the conformity assessment procedure for in vitro diagnostic medical devices.
In particular, medical device manufacturer stands for the one responsible for the design, manufacturing processes, packaging, and labeling of the products before they are placed on the market under the name of such an entity. The concept of a medical device manufacturer also covers the parties responsible for assembly, packaging, processing, and refurbishing medical devices, provided the devices are placed on the market in the name of such entities. However, it is important to mention that the above does not apply to those involved in adapting existing medical devices to be used by individual patients.
According to the guidance, a UK approved body stands for a third-party independent certification organization that the MHRA designates to carry out certain tasks in respect of the conformity assessment procedures in Great Britain. As further explained by the MHRA, a UK approved body must be qualified to perform all the functions for which it is designated; the tasks that a UK approved body can carry out may be restricted by the MHRA; and the activities of UK approved bodies are regularly monitored.
In accordance with the applicable regulatory requirements, medical device manufacturers are obliged to notify the UK approved bodies they are working with about changes to the products they are responsible for, as well as to the quality system employed. Should the design or type examination be conducted by the UK approved body, the party responsible for a medical device would also have to inform them about the changes to the design of the product in question. Furthermore, these changes are subject to prior approval by the relevant UK approved body.
The applicable legislation provides that any and all in vitro diagnostic medical devices intended to be marketed and used in the UK should comply with the relevant essential requirements introduced in order to ensure the safety of patients, as well as proper performance of such products. At the same time, the authority explicitly states that not all the essential requirements will apply to all devices, and it is up to the manufacturer of the device to assess which are appropriate for their particular product. Moreover, in order to demonstrate compliance with the applicable regulatory requirements, medical device manufacturers may also demonstrate compliance with the applicable standards.
Under the general rule, for most in vitro diagnostic medical devices, the involvement of a UK-approved body is not required in terms of the conformity assessment. At the same time, in certain cases, such involvement would actually be required. As further explained by the MHRA, when it comes to the conformity assessment procedures for IVD products, they could be divided into four categories:
- General IVDs, i.e., all IVDs other than those covered below;
- IVDs for self-testing (a device intended by the manufacturer to be able to be used by lay persons in a home environment), excluding self-test devices covered below;
- IVDs in the classification stated in Part IV of the UK MDR 2002, Annex II List B which, amongst others, includes reagent products for rubella, toxoplasmosis, and phenylketonuria as well as devices for self-testing for blood sugar;
- IVDs in the classification stated in Part IV of the UK MDR 2002, Annex II List A which includes reagents and products for HIV I and II, Hepatitis B, C, and D, and reagent products for determining ABO systems and anti-Kell including those used to test donated blood plus tests for screening vCJD.
In summary, the present MHRA guidance provides a brief overview of the regulatory requirements in the sphere of conformity assessment for in vitro diagnostic medical devices intended to be marketed and used in the UK. The document highlights the key points to be taken into consideration by medical device manufacturers and also provides definitions of the most important terms and concepts.
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