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Distance Strategy for Class I Devices Quality Management FDA 21 CFR 820 / ISO 13485 / EN 46000 LINKS TO OTHER MEDICAL DEVICE SITES UK Competent Authority - Medical Device Agency (MDA) Notified Bodies under Directive 93/42/EEC Download a copy of the Medical Device Directive 93/42/EEC now |
Summary of our Services to help Medical Device Manufacturers accomplish Successful Regulatory Compliance
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 its 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 its principle intended action in or on the human body by pharmacological, imunological or metabolic means, but which may be assisted in its function by such means..."
What is an "Accessory to a medical device"?
‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
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. Further Clasification guidance and decision tree.......more.....
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 13485:2003 or ISO 9001:2000 or Annex V 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 13485:2003 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 13485:2003 and compilation of a Design Dossier which is a more detailed Technical File. The final step is an audit by a Notified Body. There are other Conformance Routes covering Own Brand Labeling and Systems and Procedure Packs. What data must a Technical File contain and what help is available? Follow this Link for information on the content of a Technical File for Class I, Class IIa, Class IIb or Class III medical devices.
What are "Post Sales Issues" and how can I be sure that I meet all my responsibilities? Follow
this Link for advice and information on these
important issues.
If you have any questions that are not answered in the above text, or if you need a quotation for Authorized Representative Services, please follow this Link http://www.mdqaconsultancy.co.uk/
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& QA Consultancy