National foreword

This British Standard is the official English language version of EN 13612:2002, including Corrigendum December 2002

The UK participation in its preparation was entrusted to Technical Committee CH/69, In vitro diagnostic systems, which has the responsibility to:

aid enquirers to understand the text;
present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
monitor related international and European developments and promulgate them in the UK.

A list of organizations represented on this committee can be obtained on request to its secretary.

Cross-references

The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled "International Standards Correspondence Index", or by using the "Search" facility of the BSI Electronic Catalogue or of British Standards Online.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard does not of itself confer immunity from legal obligations.

This European Standard was approved by CEN on 5 January 2002.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

Foreword

This document EN 13612:2002 has been prepared by Technical Committee CEN/TC 140 "In vitro diagnostic medical devices", the secretariat of which is held by DIN.

The European Diagnostic Manufacturers Association (EDMA) has contributed to its preparation.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2002, and conflicting national standards shall be withdrawn at the latest by September 2002.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.

Annex ZA is for information only.

This standard includes a Bibliography.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

Introduction

Directive 98/79/EC on in vitro diagnostic medical devices (IVD MDs) requires in Annex III, section 3, indent 11 and section 6.1, in Annex IV, section 3.2 c) and in Annex V, section 3, that the manufacturer provides evidence in his technical documentation that the IVD MD performs as claimed, whether these claims are of a technical, analytical or diagnostic nature. Such evidence can be shown by data already available to the manufacturer or by scientific literature or by data originating from performance evaluation studies in a clinical or other appropriate environment in accordance with the intended use.

If a performance evaluation study is necessary and appropriate to support performance claims of the IVD MD, this standard describes how the manufacturer can fulfil his obligation to conduct a scientifically sound performance evaluation study. The evaluation plan is adapted to the nature of the IVD MD and its intended use, taking into account the various recommendations given in standards and scientific literature.

Considering the broad range of IVD MDs covered by Directive 98/79/EC and taking into account that, up to now, there is no uniformly applicable document, it is the purpose of this standard to present the common elements to be considered for a performance evaluation. The applicability of many items described will depend on the level of complexity of the IVD MD.

At the time of drafting this standard it was envisaged that the European Commission would publish a number of Common Technical Specifications (CTSs) which would be relevant to Directive 98/79/EC on in vitro diagnostic medical devices. It was further envisaged that these would be referenced in the Official Journal of the European Communities. In particular these CTSs will apply to in vitro diagnostic medical devices falling into list A of annex II of the Directive 98/79/EC and possibly a number of in vitro diagnostic medical devices in list B of annex II of the same directive. Manufacturers should therefore take these CTSs into account within the context of Article 5 "Reference to standards", of the Directive 98/79/EC.

1 Scope

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.

2 Terms and definitions

3 General requirements for the performance evaluation

3.1 Responsibilities and resources

3.2 Documentation

3.3 Final assessment and review

4 Organisation of a performance evaluation study

4.1 Preconditions

4.2 Evaluation plan

4.3 Sites and resources

4.4 Basic design information

4.5 Experimental design

4.6 Performance study records

4.7 Observations and unexpected outcomes

4.8 Evaluation report

5 Modifications during the performance evaluation study

6 Re-evaluation

7 Protection and safety of probands

Bibliography

BS EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

Current, Under Review

Published:

7 May 2002