The new article highlights the aspects related to conformity assessment 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 medical devices, has published a guidance document dedicated to the regulation of In -Vitro diagnostic (IVD) medical devices.
This document summarizes current regulatory requirements and offers essential compliance guidance to medical device manufacturers for Conformity Assessment.
The authority retains the prerogative to modify guidance to reflect legislative amendments when necessary.However, the guidance are non- binding in legal nature.
IVD Conformity Assessment Routes
To demonstrate compliance with Essential Requirements, medical device manufacturers must follow the suitable conformity assessment procedures detailed in Regulation 40, Part IV of the UK MDR 2002.
These procedures are further explained in Part III of Schedule 2A to the UK MDR 2002. These sections specify requirements and protocols for various categories of IVDs namely:
- General IVDs : manufacturers must meet criteria found in sections 1 through 5 of Annex III, Part IV of the UK MDR 2002. It’s important to note that UK approved bodies’ involvement is not obligatory for these products.
- Self-test IVDs: Excluding Part IV of the UK MDR 2002, Annex II, have additional requirements. In addition to meeting General IVD requirements, manufacturers must engage a UK-approved body for assessing the device’s design before declaring conformity.
- This assessment is crucial to determine if the product is suitable for use by laypersons. Alternatively, manufacturers can choose the conformity assessment designed for higher-risk products.
Part IV of the UK MDR 2002, Annex II: Devices in Annex II List B can follow protocols in Annex IV, combine methods from Annexes V and VI, or adhere to Annexes V and VII. However, List A devices have stricter regulatory requirements, permitting only Annex IV or Annexes V and VII. Annexes V and VI cannot be used together.
All Annex II devices require involvement from a UK approved body before a medical device manufacturer can issue a declaration of conformity. Manufacturers should follow the guidelines outlined in the Annexes to Part IV while considering the amendments in Part III of Schedule 2A to the UK MDR 2002.
Classification, Documentation and Specifications
Classifications within Part IV of the UK MDR 2002, Annex II List B
As explained by the MHRA, the UK approved bodies are playing an important role in the evaluation of such products. According to the guidance, they are authorized to:
- Conduct an exhaustive audit of the full quality assurance system employed by the manufacturer
- Undertake type examination, combined with verification of each batch or the entire product
- Pursue type examination and subsequently, audit the quality assurance system implemented by a medical device manufacturer.
Moreover, for Annex II List A IVDs, an additional responsibility rests with the UK approved body: they need to validate each product or batch before it will be placed on the market.
Documentation
Certain documents, including the declaration of conformity, technical paperwork, and the verdicts and reports of UK approved bodies, must be made accessible for review for 5 years following the last device in question being manufactured.
Designated Standards
The standards established in Part IV of the UK MDR 2002 act as proof of conformity to Essential Requirements.
Following these standards, as outlined in the guidance, is seen as complying with the Essential Requirements they pertain to. It’s important to note that while these standards are a valuable tool, their use is not compulsory.
Manufacturers can opt for alternative, non-designated standards for conformity, though these won’t offer the same presumed conformity benefits.
Common Technical Specifications
The MHRA guidance extends to Common Technical Specifications (CTS) for devices in Lists A and B of Annex II, outlining performance criteria.
Any deviations require measures no less strict than standard requirements.
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