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


Medical Devices are currently regulated in the EU under 3 New Approach Directives:

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.

Change to Regulation

The current three directives will be replaced by two new regulations in the near future. Active Implantable Medical Devices and general Medical Devices will be combined into a single new regulation, which alas is still hardware-centric and makes no allowance for the all pervasive spread of software and learning technologies. In Vitro Diagnostics will have a new Regulation and a risk-based classification system, meaning that the great majority of IVDs will need Notified Body overview for the first time.


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.

Trends and Changes

In recent years while the new regulations have been delayed by the Eurocratic process, the Commission has sought to make the burden on CAs, NBs and ultimately manufacturers greater by promulgating opinions, guidance and interpretations - this process is frequently called Regulatory Creep or regulation through the back door. The new regulations will both give some democratic legitimacy to this process and extend it, hence we expect to see the reduction in the number of Notified Bodies (and manufacturers) continue as smaller enterprises will fail to have the critical mass to support the new burden.

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:

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

  1. Decide to which directive(s) you need CE mark
  2. Classify your device
  3. Check the available conformity assessment routes for that class of device
  4. Select your Notified Body, if you need one
  5. Assess your device according to Essential Requirements and Harmonized Standards
  6. Prepare your Technical File (similar to DMR)
  7. Pass any little tests your Notified Body may want
  8. Decide on your E.U. Representation
  9. Prepare your "Declaration of Conformity"
  10. ... 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!

Transition to the New Regulations

The new regulations are three times the length of the previous directive: this additional detail will naturally impact compliance. Further, significant sectors of the industry will be affected by reclassification of devices and more onerous, costly and time consuming comformity assessment processes. It is important for medical device companies to determine a startegy ahead of time and we at MeddiQuest are here to help!

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Uploaded March 20, 2005
Last updated October 23, 2015
MeddiQuest Limited: Incorporated in England under number 4226188 at BioPark AL7 3AX