EN 1041 :2008: Information supplied by the manufacturer of medical devices

Information supplied by the manufacturer of medical devices (includes Amendment
A1:2013)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references ……………………………………………………………………………………………………… 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 Requirements ………………………………………………………………………………………………………………… 6
4.1 General ………………………………………………………………………………………………………………………….. 6
4.2 Units, symbols and colours ……………………………………………………………………………………………. 6
4.3 Language and country identifiers …………………………………………………………………………………… 7
4.4 Dates ……………………………………………………………………………………………………………………………… 7
4.5 Device nomenclature ……………………………………………………………………………………………………… 7
4.5.1 Identifiers of nomenclature …………………………………………………………………………………………….. 7
4.5.2 Device common terms ……………………………………………………………………………………………………. 7
4.5.3 Batch code; lot number; batch number; lot code …………………………………………………………….. 7
5 Requirements for provision of information ……………………………………………………………………… 7
5.1 General ………………………………………………………………………………………………………………………….. 7
5.1.1 !Safe and effective use of the device” …………………………………………………………………………….. 7
5.1.2 !Address required under medical devices directives” ……………………………………………………… 7
5.2 Specific requirements …………………………………………………………………………………………………….. 8
5.2.1 Applicability …………………………………………………………………………………………………………………… 8
5.2.2 Accessibility ………………………………………………………………………………………………………………….. 8
5.2.3 Legibility ………………………………………………………………………………………………………………………… 8
5.2.4 Availability …………………………………………………………………………………………………………………….. 9
5.2.5 Security …………………………………………………………………………………………………………………………. 9
5.2.6 Changes to information provided ……………………………………………………………………………………. 9
6 Documentation ………………………………………………………………………………………………………………. 9
Annex A (informative) Requirements and guidance for Directives 93/42/EEC and 90/385/EEC, as
amended 10 A.1 Requirements and guidance for medical devices (Directive 93/42/EEC) … 10
A.2 Requirements and guidance for active implantable medical devices (Directive
90/385/EEC) ………………………………………………………………………………………………………………….. 16
Annex B (informative) Guidance on alternative labelling for instructions for use (IFU) ………………….. 20
B.1 Guidance on alternative labelling for medical devices (Directive 93/42/EEC) ………………….. 21
B.2 Guidance on alternative labelling for active implantable medical devices (Directive
90/385/EEC) ………………………………………………………………………………………………………………….. 22
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EC ………………………………………………………………………… 23
Annex ZB (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 90/385/EC ………………………………………………………………………. 24
Bibliography ……………………………………………………………………………………………………………………………….. 25