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Medical Devices Directive (MDD)

93/42/EEC

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Who Needs to Comply with the Medical Devices Directive?

The Medical Devices Directive applies to anything which is principally intended for one of the following purposes: diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or replacement or modification of the anatomy. etc. It specifically excludes active implantable devices and in-vitro diagnostic devices which are covered by their own directives, but it includes any electronic apparatus such as personal computers (and their software) which are principally used for medical purposes.

Medical Devices Directive in Brief

Like all New Approach Directives, the MDD requires that a medical product complies with a set of essential requirements relating to performance, health and safety. These requirements, focusing on the safety aspects of the design and construction, cover issues such as chemical, physical and biological properties, infection and microbial contamination, EMC, radiation, mechanical, thermal and electrical risks.

Medical Devices Directive and Routes to Compliance

The routes to compliance depend on the classification of the product:

Class I - low risk devices (eg stethoscopes, wheelchairs) these products are the least complicated and their failure poses no risk.
Class IIa - low-medium risk devices (eg hearing aids, ultrasonic diagnostic equipment) these products are more complicated and present more risk than Class I devices.
Class IIb - medium-high risk devices (eg surgical lasers, ventilators) these products present the same risk as Class IIa.
Class III - high-risk devices (eg balloon catheters, prosthetic heart valves) these products sustain or support life so their failure is life threatening.

For all classification types a Technical File must be prepared demonstrating compliance to the directives essential requirements.  Compliance can be established by showing conformity to the Harmonized Standards for the Medical Devices Directive.

Why use Technology International Group?

Technology International provides technical advice and support to clients whose products need to meet the Medical Devices Directive.  Our services include:

  • offering general advice on the scope and workings of the Directive
  • reviewing product designs against the requirements of the Directive
  • assistance with the preparation of the compliance documentation

Our goal is to help clients find the most relevant and cost-effective methods to demonstrating compliance to the Medical Devices Directive.

 

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