Co-ordination of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC

Recommendation NB-MED/2.5.5/Rec2

Title:

Combination of CE-marked and non-CE-marked medical devices and non-medical devices
2.5.5 Conformity assessment for particular product groups „If the device is intended for use in combination with other devices or equipment, the whole combination, including the connection system must be safe and must not impair the specified performances of the devices.“ systems and procedure packs, non-CE-marked medical devices, nonmedical devices, combination of medical devices, labelling of combinations

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1.

Purpose

The purpose of this recommendation is to provide guidance to the Notified Body and the manufacturer on the MDD regulatory requirements which apply to the placing on the market and putting into service of various combinations of CE-marked medical devices, non CE-marked medical devices and non medical devices. This includes guidance on the content of the technical file and information for the user in situations where medical devices are to be used in combination with other devices for a purpose within the scope of MDD. Those other devices may be CE-marked medical devices, non CE-marked medical devices or non-medical devices. This recommendation does not address spare parts of medical devices. Spare parts in general are not subject to separate conformity assessments and therefore are not subject to CE marking.

A rationale and history sheet is available; please contact Technical Secretariat. Reference to Directives: AIMD MDD IVDD Stage 3 Article/ Annex: Article: 11, 12, 22-3 Reference to standards:

proposed by ad hoc group/NBRG

Rev.-Nr. 9

Rev. date 12.01.2001

accepted 06.03.2001

amended

withdrawn

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VdTÜV Technical Secretariat NB-MED PO Box 10 38 34 D-45038 Essen

G. Hinrich Schaub (- 178) Phone: ++49/201/8987- 0 Fax: ++49/201/8987-