Medical Device Directive

The joining of European States caused all sorts of problems for harmonization in Europe. One of the principles of the European Free Trade Agreement (EFTA) is the free movement of goods across boarders. One barrier to this was the many individual national regulations for products such as toys, building materials, and medical devices. The answer was to agree on standards which could be adopted by each nation and which could then be accepted by every nation.

This principle resulted in the generation of a European Directive on Medical Devices which was required to be implemented in each nations own law and formally enforced by June 1998. After this point, medical products had to comply with the requirements laid out in the directive. After compliance a mark indicating compliance had to be affixed to each medical device manufactured
– the CE mark.

The legislation is very sensible and practical. It calls for good practice in design and good practice in production. It distinguishes between potentially risky devices and safer devices by a classification system that is based on use. For instance, a device which is designed to be temporarily invasive during surgery is more risky than a device which is not invasive at all. The more risky the device, the greater the proof required before the CE mark can be applied. The directive provides a variety of routes for the manufacturer to prove good practice. A manufacturer can choose to have a product "type tested" or even to have their production output independently inspected.

One of the principles of all directives in Europe is that if a manufacturer can demonstrate compliance with a harmonized standard (one adopted by Europe) thrpugh an appropriate means, then they need not go through the process again. One of the requirements for some medical devices is the need to establish a formal quality assurance system. Whilst the legislation does not demand it, compliance with ISO 9000 "like" standard EN 46000 covers the QA requirements of the medical device directive and, at the same time, gives manufacturers the ISO 9000 banner as well.

The Medical Device Directive requires much more than just a formal quality system. Medical auditors must check technical documentation, risk analyses, design files, etc. to give them assurance of the efficacy and safety of the product.

What does the manufacturer gain? Especially one outside of the European community? Access to the largest trade area in the world with a single product assessment.

Cavendish Scott provides all types of training, consulting, and assistance to companies wishing to comply with the requirements of the Medical Device Directive.

 

..... Home