MDR on Good Laboratory Practice (GLP) - Pg 110, section 6.1 (b)

T

thenewbiemdr

#1
Hi All :bigwave:,

I have few questions regarding about MDR Pg 110, section 6.1 (b),

Question 1:

"where applicable, conformity with the provisions of Directive 2004/10/EC of the European Parliament and of the Council (1) shall be demonstrated."

So, as above,as a manufacturer, when do we use GLP for product testing?

Question 2:

And, "where no new testing has been undertaken, the documentation shall incorporate a rationale for that decision."

Is this required for new product testing only for material?

If yes,only selective testing will be required such as it can be either physical testing, biological testing or chemical testing or all testing have to be done?

Pls advice. Thank you :)
 
Elsmar Forum Sponsor
#2
To Question 1 - in our case biocompatibility tests should be done by test lab which has both ISO\IEC 17025 accreditation and GLP certification
 

MrTetris

Involved In Discussions
#3
Is Directive 2004/10/EC really applicable to biocomp tests of medical devices?
The directive itself says that it is applicable to non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. It does not mention medical devices...
MDR says "where applicable"... perhaps it is not applicable, if the medical device does not contain pharmaceutical products (or one of the other products listed above)?
 
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