Technical Guidance Note 10

TOPIC: Must Medical Devices carry the CE mark?

ISSUE: 4

REVISION DATE: 6.11.98

PREVIOUS REVISION DATE: 27.1.98

BACKGROUND: The UK's EMC regulations have been amended by SI 1994 No. 3080 to include Medical Devices.

PROBLEM: When must Medical Devices carry the CE mark?

GUIDELINES:

From 14.6.98 Medical Devices must comply with the Medical Devices Directive and have the CE mark affixed.

Disclaimer
No responsibility or liability can be accepted by the EMC Test Laboratories Association or any of its officers or members for the contents, specifications and/or advice referred to or contained in this Technical Memorandum and/or action taken as a result of information contained in this Technical Memorandum. Note that:
1. The Association is not by supplying this Technical Memorandum providing professional advice or guidance to any specific party on any specific matter and no legal relationship is created by the provision of this Technical Memorandum.
2. Parties should take specific advice when dealing with specific situations and consult their own professional advisors in this regard.
3. Members are free to deviate from the above guidelines where they think it appropriate, unworkable, or not commercially viable. Under these circumstances, the EMCTLA Secretariat should be informed of the reasons for the deviation so that the matter can be reviewed.