MDD Directive

What is a 'Medical Device'?
 
According to the European Medical Device Directive (93/42/EEC), a Medical Device is;
"...any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for it's proper application intended by the manufacturer to be used for human beings for the purpose of;
 - diagnosis, prevention, monitoring, treatment or alleviation of disease,
 - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
 - investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
 
and which does not achieve it's principle intended action in or on the human body by pharmacological, imunological or metabolic means, but which may be assisted in it's function by such means..."
 
 
What is classification and how do I correctly classify my Products?
 
Classification is the process whereby a medical device is placed into one of four categories, dependant on the device's potential to cause harm to the patient, user or other person. This is a very important step in any compliance strategy because the classification determines the Conformance Route. The lowest risk devices fall into Class I, whilst devices which exchange energy with the patient in a therapeutic manner or are used to diagnose or monitor medical conditions, are in Class IIa. If this is done in manner which could be hazardous for the patient, then the device falls into Class IIb. Class IIb is also reserved for implantable devices or where absorption takes place. If a device connects directly with the Central Circulatory System (CCS) or the Central Nervous System (CNS) or contains a medicinal product, then the device falls into Class III.
 
 
Which Conformance route is appropriate for my Products?
Class I Devices - Generally, require just Internal Control of Production and compilation of a Technical File. The Technical File then has to be held in case of a request by a Competent Authority. The final step is Self Certification and Registration with a Competent Authority.
Class IIa Devices - Require a Quality Management System to ISO 9002 + EN 46002 and compilation of a Technical File. The final step is an audit by a Notified Body.
Class IIb Devices - Require a Quality Management System to ISO 9001 + EN 46001 and compilation of a Technical File. The final step is an audit by a Notified Body.
Class III Devices - Being the highest risk devices, it is necessary to implement a Quality Management System to ISO 9001 + EN 46001 and compilation of a Design Dossier which is a more detailed Technical File. The final step is an audit by a Notified Body.
 
 
 
Which Conformance route is appropriate for my Products?
Class I Devices - Generally, require just Internal Control of Production and compilation of a Technical File. The Technical File then has to be held in case of a request by a Competent Authority. The final step is Self Certification and Registration with a Competent Authority.
Class IIa Devices - Require a Quality Management System to ISO 9002 + EN 46002 and compilation of a Technical File. The final step is an audit by a Notified Body.
Class IIb Devices - Require a Quality Management System to ISO 9001 + EN 46001 and compilation of a Technical File. The final step is an audit by a Notified Body.
Class III Devices - Being the highest risk devices, it is necessary to implement a Quality Management System to ISO 9001 + EN 46001 and compilation of a Design Dossier which is a more detailed Technical File. The final step is an audit by a Notified Body.