CEN/TC 140/WG 1 - Labelling and performance evaluation

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.
NOTE   For a selection of publications on specific evaluation plans see Bibliography.
Where a manufacturer maintains a quality system this standard addresses the compliance with "design validation" and "design changes" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs.
In particular, this standard applies to IVD MDs to
- show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer,
- establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to
- satisfy the requirements of a quality system for design validation.

This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, which hereafter are called IVD reagents.
NOTE   This standard can also be applied to accessories.

This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus and equipment for self-testing which hereafter are called IVD instruments.
NOTE 1   Instructions for use are essential to enable the safe and proper operation of IVD instruments by lay persons.
NOTE 2   This standard can also be applied to accessories.
This standard is not applicable to field repair instructions.

This standard specifies the requirements for the contents of user manuals for in vitro diagnostic instruments including apparatus and equipment for professional use, hereafter called instruments. Note 1: User manuals are essential to enable the safe and proper operation of instruments. Note 2: This standard can also be applied to accessories. This standard is not applicable to field repair instructions.

This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits for professional use, which hereafter are called reagents. Note: This standard can also be applied to accessories.

This standard provides requirements for the marking of in vitro diagnostic instruments. In connection with electrical equipment for laboratory use the requirements are additional to those specified in 5.1 to 5.3 of EN 61010-1 : 1993.  An easy to understand uniform marking of in vitro diagnostic instruments is important for their safe and correct handling.

This standard specifies the content of user manuals for in-vitro diagnostic instruments for home use. User manuals are essential to enable the safe and proper operation of instruments by trained and untrained personnel. This standard is not applicable to  field repair instructions.

This standard specifies requirements for the labelling of in-vitro diagnostic reagents which are intended for use in self-testing, i.e. for lay use. The term "self-testing" intends both  patient self-testing (i.e. home-testing carried out by patients under the supervision of their physician) and consumer self-testing (i.e. testing carried out by the lay public on their own initiative).

This standard specifies user manuals for in-vitro diagnostic instruments for professional use. User manuals are essential to enable the safe and proper operation of instruments. This standard is not applicable to field repair instructions.

This standard specifies requirements for the labelling of in-vitro diagnostic reagents for professional use.