MeddiQuest - E.U. Medical Device Regulation

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This is a simplyfied overview! We specialize in assisting manfacturer's to determine their strategy for meeting these requirements and then providing the necessary training, resource or expertise to implement it. Contact Us

Legal Basis

Directives

Medical Devices are regulated in the EU under 3 New Approach Directives. (A fourth tissue products directive will follow shortly.)

Active Implantable Medical Device Directive, AIMDD (90/383/EEC)
Medical Device Directive, MDD (93/42/EEC)
In Vitro Medical Device Directive, IVMDD (98/79/EC)

EU Directives need to be transposed into law by national governments; this process is rarely complete and leads to differences of interpretation between the various states of the European Union.

The concept of New Approach directives is that there are some basic verities, called Essential Requirements, ER's, about all products falling within the scope of the directive: if these are satisfied then the device is fit to be marketed in Europe. The various directives specify these Essential Requirements but deviate slightly from the true New Approach concept by classifying products according to risk and applying an increasing requirement for third-party verification as the risk-class increases.

Authority

Each member state of the EU will specify a Competent Authority, CA to enact the directive. Each CA can specify one or more Notified Bodies, NB, to act as third party assors of the firms compliance. A NB may be Notified for all products under the particular directive or only a sub-set of them. There is no requirement on a CA to appoint a NB within their borders, let alone one for every device type under any particular directive.

Other Directives

There are many directives in the EU. Compliance with one directive may automatically deem the product to be compliant with another, or it may not! Some other important directives for the Medical Device Industry are:

Machinery
General product Safety
Low Voltage
EMC

Remember the Machinery Directive will apply to production/process equipment transfered to the EU if it fulfills the definition of a machine. Note: No Sale is necessary!

The CE Marking Process

Decide to which directive(s) you need CE mark
Classify your device
Check the available conformity assessment routes for that class of device
Select your Notified Body, if you need one
Assess your device according to Essential Requirements and Harmonized Standards
Prepare your Technical File (similar to DMR)
Pass any little tests your Notified Body may want
Decide on your E.U. Representation
Prepare your "Declaration of Conformity"
... and affix your C.E. Mark

Easy? Well maybe not easy, but it is reasonably straight forward .... ah, but people have fallen at every step! There are a lot of possibilities and many routes, the objective is to find the best one for your business - and that's where MeddiQuest can help: We'll tell you the options, the implications and let you decide!