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Best practices in utilizing old clinical studies

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Guest user Created:   Oct 11, 2021 Last commented:   Oct 14, 2021

Best practices in utilizing old clinical studies

What are the Best practices in utilizing old clinical studies for a product which is already on market for the last 15 years?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Oct 12, 2021

If you have a medical device that is on the market for more than 15 years, then in clinical evaluation you can use all clinical information that you have.

For more information regarding this topic please see the following guidance:

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Guest user Oct 12, 2021

Thanks Kristina. I am now reading the guidance :)

Another question I can think of is Intended purpose under MDR. The definition of Intended Purpose is not clear in MDR. There is MEDDEV guidance meddev 2.7/1 rev 4 which has given some clarification on what should be in Intended Purpose.

For products which have already got 510(k) clearance, companies do not want to change Intended Purpose/Intended Use. What are the best practices in this area which companies can follow?

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Kristina Zvonar Brkić Oct 14, 2021

In Article 2 Definitions, in point 12 is stated that “‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation“. The intended purpose would be best put together by someone who has experience with a given medical device keeping in mind the intended user (medical professional or patient or other users). It is usually a short two- or three-sentence statement focusing on what the device is intended to be used for. With the intended purpose, it is proven that the product has a medical purpose, in line with the definition of a medical device in paragraph 1 of Article 2.

The intended purpose must in no way refer to specific features of the product or the specifications of the intended product

For further information, please see the following:

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Oct 11, 2021

Oct 14, 2021