Yep, you will find most Notified Bodies do not know the content of the MPD in detail, so the default would be material selection, material composition, material characterisation, and then summarising in a biological evaluation file.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------
Original Message:
Sent: 03-Jul-2023 14:36
From: Katarzyna Chrusciel
Subject: GSPR 12.2 of MDR
Thank you Richard!
Yes, we have already prepared the BEP based on EN ISO 10993-1 and started to perform the tests.
I will send the request to the NB if this will be acceptable for them.
I will share their feedback.
Kate
---------------------------------
Katarzyna Chrusciel
Original Message:
Sent: 03-Jul-2023
From: Richard Vincins
Subject: RE: GSPR 12.2 of MDR
Good day Katarzyna,
I have been working with a couple companies on this regard, and I would say it is not exactly so clear exactly what needs to be performed. However, from a medical device perspective we have been using ISO 10993-1 standard and the series to address aspects of absorption and such. I have not looked at Annex I from the MPD in a while, so not sure what are the requirements, but as a "medical device" we had been using ISO 10993 series creating a Biological Evaluation File.
------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 01-Jul-2023 14:16
From: Katarzyna Chrusciel
Subject: GSPR 12.2 of MDR
Hello everyone.
I have a question related to the general safety and performance requirement GSPR 12.2 of MDR. This is new requirement related to the devices composed of substances absorbed or locally dispersed (e.g. fillers). These devices must to comply with relevant requirements of Annex I to the medicinal MPD 2001/83/EC, which cover analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of drug products.
Based on you drug related experience, which standards, lab tests and guidelines would you advise for evaluation of absorption, distribution, metabolism, excretion and local tolerance?
Thank you in advance.
Kate
---------------------------------
Katarzyna Chrusciel
---------------------------------