The Medical Devices Directive is concerned with all medical devices, from sterile Gants to electronic monitoring equipment and complex MRI-scanners.
ce-test has been performing a number of medical equipment assessments , both in the Class I and Class II categories.
Examples of products we assessed are:
- Dry sterilizer (Class I)
- Tactile vibration test generator (Class I)
- Tactile hot-cold test generator (Class I)
- Nurse calling system for hospital including medical alarm
- Bed wetting alarm (Class IIa)
- Medical gas alarm (Class I)
- Infusion pump (Class IIa)
( Purchase Medical Symbols in True Type Font)
Class I equipment
Class 1: non-invasive electric/electronic equipment without a monitoring function.
For this type of medical equipment the so-called manufacturers declaration is applicable and no involvement of any certified or notified body is required.
Class II equipment
Class II : non-invasive or short time invasive equipment or intensive patient skin contact or administration of body fluids or medicinal fluids or gases.
Class II equipment requires the involvement of a Notified Body that will approve customers documentation.
Technical Construction File
A Technical Construction File (TCF) is mandatory. The full construction details of the equipment and all measures taken to comply to the directive¡¯s Essential Requirements must be created and maintained.
Any medical device requires a risk assessment according to EN 14971:2000. This includes a analysis of construction, applied materials, energy flows, bio-compatibility , infection and cross infection risks and many other product properties.
The Medical Devices Directive uses harmonized standards to show presumption of compliance with the essential requirements of the directive. For Class I and II equipment these requirements are:
The equipment should comply with EN 60601-1-2:2000.
The equipment should comply to EN 60601-1:2000.
Risk Management Assessment
A full risk assessment is part of the approval procedure for medical devices. ce-test may perform such a risk assessment according to the FMEA (Failure Mode and Effect Analysis) and a bi-directional TOP-DOWN-TOP FTA (Fault tree Analysis) methods.
Products need to be traceable for manufacturing and production sources, and towards the distribution of the final product.
Quality control of production
Production of medical devices need to be under control of an intern manufacturing control system like ISO 9002 or better.
The manufacturer needs to set up and maintain a system where accidents with the device and near accidents with the device will be adequately reported to the authorities; in combination with a trace ability system product recalls may be organized if required.
Post market surveillance
The manufacturer needs to watch for product improvements, and implement them in the final product as soon as possible, even after the product has been brought on the market.
The EN 60601 standard contains extensive requirements for patient touch current, dielectric testing and single fault requirements as well as EMI and susceptibility tests.
We have both experience and the test lab required to perform such a complex suite of tests.