Medical Devices are 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, 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 principal intended action in or on the human body by pharmacological, immunological or metabolic means.
Depending on its Intended Purpose, Medical Devices are classified as Class I, Class IIa, IIb and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required. In Medical Devices classification we have to consider following factors, including,
- How long the device is intended to be in continuous use
- Whether the device is invasive or surgically invasive,
- Whether the device is implantable or active
- Whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
The classification rules are set out in Annex IX of the directive. This annex includes definitions of the terminology used in the classification rules for each class of Medical Devices
Based on the classification we can prepare the Technical file for the classified Medical Devices
The Technical file Should Include following Details
- The company Details like Address, location, Premises plan, Authorized Person for contact, Authorized EU Representative Address, and a legal documents to Prove the company details.
- The Device Details like , exact name of the device ,indented use ,Mechanism of action, Packing details , storage condition. We have to attach the specimen IFUs, labels , outer carton and shipment labels etc . The label should comply with the Requirement of ISO 15223-1.
- The Device Manufacturing Details including clean Room atmosphere and sterilization a most important part of technical file. In case of sterilization Process we have to submit the control procedure, validation reports to prove the efficiency of the clean room and the Sterilizer. we can do the validation through the Recognized External Agencies. In this portion also should have a complete description about the incoming, in process and final inspection in order to prove the safety and Quality of the product.
- The Technical file should have the Risk Assessment Portion as per the standard ISO 14971In this we have to analyze the possible errors that may be occurs during the usage and give an account that how it can avoid or minimize. This can be given as a warning or caution in the Product In sheets.
- The Biocompatibility Test Reports as per EN ISO 10993-1:2009 these Test Reports are mandatory in Technical file We have to submit the Clinical Evaluation Reports with the Technical file for CE Marking.
- Should submit the Accelerated stability study reports to prove the stability of the Medical Devices
- The Technical file should have a general description about the purchase process , critical raw materials and their approved suppliers. Attach the material safety data sheeth for each material.
Malesh M
Regulatory Consultant
+91 9900 3218 14
Health Care Regulatory and QA Consultants 