NIST GCR 01-815
A Guide to the EU Medical Device Directive
- the instructions for use must also include details allowing the medical staff to brief the patient on any contra-indications and any precautions to be taken. These details should cover in particular:
- precautions to be taken in the event of changes in the performance of the device;
- precautions to be taken as regards exposure, in reasonably foreseeable environmental conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or variations in pressure, acceleration, thermal ignition sources, etc.;
- adequate information regarding the medicinal product or products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered;
- precautions to be taken against any special, unusual risks related to the disposal of the device;
- medicinal substances incorporated into the device as an integral part in accordance with Section 7.4; and
- degree of accuracy claimed for devices with a measuring function.
V. European Harmonized Standards
Since the Medical Device Directive lays down essential requirements in very general terms, standards can be important guides for the manufacturer. Standards interpret the safety objectives and also provide a technical route to compliance.
While compliance with the Medical Device essential requirements is mandatory, the use of Medical Device Harmonized Standards* is voluntary. However, the Directive instructs the manufacturer in the order in which standards are most likely to assure compliance.
A. Harmonized Standards
The most direct route to compliance through standards is the use of Medical Device Harmonized Standards. A manufacturer who uses Medical Device Harmonized Standards in the design and production of devices is presumed in conformity with the essential requirements of the Directive (See NIST SP 951 A Guide to EU Standards and Conformity Assessment, Page 11). The use of Harmonized Standards* is the most direct route to compliance with any New Approach Directive
* PDF file format requires the FREE ADOBE ACROBAT READER Software.
If you are unable to use the ADOBE ACROBAT READER Software and require a copy of a PDF document, please request a copy to be sent to you from maureen.breitenberg@nist.gov
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