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AIMDD instruction was drawn up in 1990 and was applied for compulsory matters since January, 1995. Therefore, selling active implant medical device in Europe must paste CE tags. Manufacturers must prove to the certification authorities that products which paste CE tags meet the AIMDD instructions:
Type testing
Designing evaluation
Medical device evaluation for producers (ISO13485/ ISO9001)
Clinical report evaluation
Meet the requirements on all the medical devices instructions.
Osmunda, a consulting organization engaged in medical devices regulations consulting, medical devices registration agent, medical device managerial system certification and medical device products certification, focuses on providing international medical device registration, medical device system certification for medical device enterprises. Besides, osmunda can help medical device suppliers with audition of the second and third party and examine goods for export, providing information of manufacturing license consulting service.
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