EU Medical Device Regulations

S

Suresh Chander

Registered
#1
#1
I am fresh with minimal knowledge about MDR Procedure and system packs. Procedure pack has class I, class IIa, IVD and other imported class I devices. Assembled and sterilized by us. My questions are :
1. What are the laboratory tests has to be carried out for procedure packs? Where to refer the details?
2. How to assign GMDN code when there is a mixture of MDs in the procedure pack? Reference links pls.
3. On what basis risk assessment and clinical evaluation has to be carried out?
Your valuable guidance is highly appreciated.
 
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S

StepPCHen

Involved In Discussions
#2
#2
Suresh Chander said:
I am fresh with minimal knowledge about MDR Procedure and system packs. Procedure pack has class I, class IIa, IVD and other imported class I devices. Assembled and sterilized by us. My questions are :
1. What are the laboratory tests has to be carried out for procedure packs? Where to refer the details?
2. How to assign GMDN code when there is a mixture of MDs in the procedure pack? Reference links pls.
3. On what basis risk assessment and clinical evaluation has to be carried out?
Your valuable guidance is highly appreciated.
Click to expand...
1. Cleanroom Validation, Bioburden Testing, Environmental Monitoring (Contact and Settle Plates), Sterilisation Validation, Sterilisation Residual testing.
2. We use 33961 but this may different to your product
3. Clinical Evaluation Report must be completed for all devices regardless of class. The CER will be based upon your Device, you can try the equivalence path.
 
S

Suresh Chander

Registered
#3
#3
StepPCHen said:
1. Cleanroom Validation, Bioburden Testing, Environmental Monitoring (Contact and Settle Plates), Sterilisation Validation, Sterilisation Residual testing.
2. We use 33961 but this may different to your product
3. Clinical Evaluation Report must be completed for all devices regardless of class. The CER will be based upon your Device, you can try the equivalence path.
Click to expand...
Thank you Mr. StepPCHen for the support.
 
T

TCSS2023

Registered
#4
#4
my 2cents even though I am also still learning MDR.
2. Not sure if GMDN is still relevant since there is EUDAMED now. There is also no mention of the GMDN within the MDR document if I am not wrong.
 
Newbie22

Newbie22

Starting to get Involved
#7
#7
The Global Medical Device Nomenclature (GMDN) will be the standard nomenclature used for the UK market under the future UKCA regime & is already required when registering devices onto the MHRA database. Hence, not referred to for the EU market :)
 
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