Medical Device supplier - obligation to support a device for a period of time ?

• Lou Ward
  02/10/2020 12:53

  Is there an obligation on a medical device supplier to support a device for a period of time eg: 7 years under any of the directives eg: MEDDEV ie. is there no minimum lifetime of the product the manufacturer is expected to ensure - I could state the product has a 6-month lifespan and then sell it into a trial lasting 10 years - am I in breach of my medical device responsibilities? I know that CE marking needs the manufacturer to calculate the lifetime of the device and that in the Tech File under 14971 Annex C asks What determines the lifetime of the medical device? Any advice gratefully received to clarify - many thanks.
• Quality Smart Solutions
  13/10/2020 08:16

  The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains obligatory necessities for manufacturers, importers, and device client offices to report certain device-related unfriendly occasions and item issues to the FDA. The regulation indicated that reports be recorded on the FDA's Medwatch Form 3500A or an electronic same. The FDA distributed the last rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic arrangement that the FDA can measure, survey, and document. This rule will be compelling as of Aug.14, 2015.

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