• Wish to place a new medical device on the European market?
  • Unsure about the product classification?
  • Need to identify an appropriate conformity assessment route to the CE mark?
  • Concerned about selecting a Notified Body?
  • Need to prepare the Technical File?
  • Need to comply with post-market requirements?
  • Want to know how the revisions that took effect from 21 March 2010 affect you?

All medical devices placed on the market in Europe must comply with one of the European Directives for medical devices, namely the Medical Device Directive 93/42/EEC, the In Vitro Diagnostic Directive 98/79/EC, or the Active Implantable Medical Device Directive 90/385/EEC, and carry the CE mark as the legal indication of compliance.

In fact, ‘CE’ is an abbreviation of ‘Conformité Européenne’, and may be found on many other items, to indicate compliance with the European directive or directives that apply to that specific type of product including, amongst others, machinery, electrical/electronic equipment, pressure vessels and personal protective equipment.  The CE mark allows the products to be marketed in the EU without trade restrictions.

The mark is affixed by the manufacturer to the product after completing an appropriate conformity assessment process, at the manufacturer’s option.

For medical devices, the routes available for manufacturers to obtain the CE mark depend on a number of factors, including risk classification, type of product, internal quality management system and human/technical resources.  For higher risk devices, the CE mark can be affixed only after involvement of a Notified Body, to either verify compliance of the product with the Directive’s ‘Essential Requirements’ and/or the manufacturer’s quality system with regulatory requirements.

Once your device is on the market, additional requirements apply in relation to the reporting of adverse incidents to the Competent Authorities designated by each EU member state.

Rocky Scientific can help your company comply with these often complex European requirements, including answering questions such as:

  • Is my product a Medical Device?
  • If so, what is its classification?
  • How do I show it complies with the Essential Requirements?
  • How do I construct a Technical File?
  • What must I do to meet the risk management requirements?
  • Does compliance with international/national standards help?
  • How do I prepare a clinical evaluation report?
  • Do I need a Notified Body?
  • If so, how do I select one?
  • Do I need a certified quality management system?
  • Does my device labelling meet the requirements?
  • What do I need to do if I assemble procedure packs?
  • What should be included on my Declaration of Conformity?
  • What are my post-market reporting obligations?

The AIMDD and MDD have recently been amended by a revising directive that has affected a number of important aspects of implementation, without a formal transition period. In addition, no ‘grandfathering’ is allowed, so all devices, even those that have been CE marked for a number of years, will have to be shown to meet the revised requirements. Probably the two most important revisions are the confirmation that clinical data must be provided for all classes of device, unless justified, and that ‘usability’ data is also now required. Rocky Consulting can advise you how these changes are likely to have affected your devices and business.

Rocky Consulting provides a fully comprehensive service to help you market your medical devices in Europe, from simply answering one of the above questions to a significant involvement in quality system assessment, technical file preparation, including standards identification, Essential Requirements compliance, risk analysis, clinical evaluation and manufacturing documentation, together with post-market reporting.
Feel free to contact us and see how we can assist you