In Vitro Diagnostic Medical Devices Explanation
SCOPE AND LEGAL DEFINITIONS
The scope of 98/79/EC applies to IVD medical devices and accessories, which can include not just reagents and kits but also instruments and software.
Article 1 of 98/79/EC gives the legal definitions which confirm that IVDs are a specific category of medical devices with particular differences and are therefore controlled under this separate Directive. It builds upon the basic medical device definition to state that:
• “An IVD medical device is any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: concerning a physiological or pathological state; or concerning a congenital abnormality; or to determine the safety and compatibility with potential recipients; or to monitor therapeutic measures.”
This also includes specimen receptacles, but general laboratory equipment is excluded. The first step for any manufacturer is to determine that their device actually falls under the above definition, with a clear medical purpose.
ESSENTIAL REQUIREMENTS (ER) AND HARMONISED STANDARDS
98/79/EC, because it has to apply to the whole spectrum of IVDs, does not define specific technical factors but instead identifies broad based essential safety requirements to be met by all devices. More detailed technical solutions to compliance are given by the specifically developed or adopted European harmonised standards, which give a “presumption of conformity” to particular areas of the Essential Requirements (ER) in Annex I of the Directive. ISO 13485 is recognised as the harmonised standard for regulatory quality system compliance, and all such standards are published in the EU’s Official Journal.
CONFORMITY ASSESSMENT ROUTES AND NOTIFIED BODY ROLE
As a New Approach Directive, 98/79/EC aims to give manufacturers different options to reach conformity with the requirements. These different conformity routes are dependent on the classification of the device and hence are linked to the perceived risk of that product.
Under the EU’s regulatory scheme, each national Competent Authority has responsibility for the implementation of the Directive in their country, but pre-market approval is delegated to specifically designated independent third parties called Notified Bodies. For higher risk devices (List A, List B and Self-Test) this means that the manufacturer must gain independent certification by a Notified Body in order to complete the conformity route process, apply for CE Marking and be able to place the device on the European market.
For the very highest risk devices in List A, there are additional measures required to address this high risk. Under the Full QA conformity route of Annex IV, each List A device must undergo a detailed review of the technical documentation called the EC Design Examination.
Once approved for CE Marking, by either of the permitted routes, every batch of List A product has on-going batch verification before it is released into the market to ensure the continued consistent performance of the device.
