Some products may be considered as 'borderline'. This means that whether or not a product is considered to be an in vitro diagnostic medical device may not be clear immediately and a manufacturer may need to seek further information in order to determine whether the regulations apply.
The Directive specifically excludes some types of products, for example, Article 1 section 2 (b) states that general laboratory products are not covered by it's remit unless, in view of their characteristics, they are specifically intended by the manufacturer to be for in vitro diagnostic examination of human samples. Thus it will depend upon the intended purpose for the product and the claims for it as to whether or not they would be considered to be IVD medical devices. It also specifically includes some products, for example specimen receptacles.
Some medical devices may have both specimen collection and analytical functions an it may not be clear which Directive should apply (93/42/EEC or 97/79/EC). In these cases the principle intended purpose for the product is taken into account.
Devices intended specifically for 'research use only' are not usually considered to come within the remit of the directive. This means that the product must have no medical intended purpose, no medical objective and not be intended for performance evaluation purposes.
Clarification of the definitions of 'performance evaluation' and 'research use only' are contained within the European Commission's guidance document MEDDEV 2.14/2 (external link). Products intended for research use only should be clearly labelled as such.
Guidance documents are available from the European Commission on the borderlines for IVD Medical Devices (MEDDEV 2.14/1 external link).
