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IVD Approval

Approvals - Europe

Medical Devices

Particularly in Europe, the type of device you are seeking clearance, approval and or registration on is addressed by different regulations known as Directives.  The three directives affecting medical devices in Europe are:

AIMD        Active Implantable Medical Device Directive    Implanted defibrillators, drug delivery
                                                                                          systems, pacemakers, etc.

IVDD           In Vitro Diagnostic Directive                           IVD reagents, controls, calibrators, systems

MDD           Medical Devices Directive                              Basically all other medical devices

Compliance with AIMD and many times with MDD or IVDD requires quality systems certification by a 3rd party assessment agency known as a Notified Body.  What determines whether or not such certification is required is the level of risk of the products.  In addition to Quality Systems (ISO 9000) certification, product related requirements may be subject to review by a Notified Body, or the company may be required to comply on "their own".

Non-Medical Devices

If you manufacture a product not considered a medical device, that is a product which is used for diagnosis or treatment, then there are still directives which may affect you including:

EMCD        Electromagnetic Compatibility Directive         Anything susceptible to or emitting EMI/RFI
                                                                                    anything electronic, with motors (lawnmowers)

LVD            Low Voltage Directive                                 Anything using an electrical energy source of
                                                                                   batteries or mains (AC)

MD             Machinery Directive                                     Anything with moving parts

PWD          Packaging & Waste Directive                      Anything with excessive plastic nonrecyclable
                                                                                  packaging

HMBD        Heavy Metal Battery Directive                     Anything containing heavy metal (cadmium)
                                                                                 batteries

As a minimum, if any of these non-medical, or  horizontal directives apply, a file must be prepared demonstrating conformity with the terms of the directive, as well as any harmonized standards which have been recognized for use with the directive.  In addition, an official party representing your firm in Europe, known as an Authorized Representative must be under contract and hold the file on your behalf in the event one of the national inspectors wishes to review it, as in the case after a mishap or accident.  

Technical Files  and Authorized Representative for CE Marking

The CRO Group can help you prepare the technical files required for CE Marking for all products.  By using one of our three programs, it is assured that the technical files will be prepared the way your Notified Body expects, including all the checklists, summaries, and support information. 

The CRO Group is an Authorized Representative in Europe.  For medical device companies without an office in Europe, this is an absolute must for CE Marking.

Technical files include Declarations of Conformity and certifications of test compliance from accredited agencies such as UL, CSA, TUV, etc.  For a general explanation of the types of testing involved, click here.

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