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Medical Devices Directive (93/42/EC as amended by 2007/47/EC)
The Medical Devices Directive is a complex set of requirements, applicable to a very wide range of products. It does not apply to in vitro diagnostic devices, active implantable devices covered by Directive 90/385/EEC, and a number of other defined types of product.
There are a number of classifications (I, IIa, IIb and III), which have different requirements in terms of the conformity assessment procedures which have to be applied.
Class I Medical Products are Non-invasive low risk (electric/electronic) equipment or devices without a monitoring function. For this type of medical equipment the manufacturer's declaration is applicable and the involvement of a Notified Body is not normally required although there are exceptions.
The other classes of product do require the involvement of a Notified Body in the conformity assessment procedures, which include Type Examination and Quality Assurance.
The manufacturer must declare that the products concerned meet the provisions of the directive. The CE mark may then be affixed to the device. The manufacturer or its authorized representative for the marketing of the product must register its activities with the competent authority of the member country in which the registered business is located.
Baseefa services include:
- Advising on the applicability of the Directive, and the applicability of standards to products.
- Providing assistance on gap analysis and pre-compliance testing.
- Carrying out, or assisting with the conducting of testing of the product, as required by the relevant standards.
- Providing assistance with technical file preparation, quality system preparation, and arranging for appropriate Notified Body services.
- Evaluation of technical documentation.
- Providing specially arranged training courses and seminars on compliance tailored specifically to your needs.
- Issue of compliance reports and certificates of compliance.
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