MDD VS MDR 2002-218

Hiro@162

Starting to get Involved
#1
Dear All,

We are currently distributing Class IIa medical devices in the UK market.
And we are in the process of registering our products with UKRP and MRHA.

Questions
Our QMS complies with the MDD (in preparation for the MDR transition).
If there are any major differences between MDD and MDR 2002-218?

Thanks,
Hiro
 
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dgrainger

Trusted Information Resource
#2
The UK is now running 2 regulatory systems - EU's MDR in Northern Ireland and a MDD based system in the rest of Great Britain until 2023. If you have a valid CE mark you are good for both markets as long as you comply with registration and UKRP requirements.

From 2023 you will need a UKCA mark for the GB market.
 

Hiro@162

Starting to get Involved
#3
Dear dgrainger,

Thank you very much for your help.

As far as I can check The Medical Devices Regulations 2002, UK legislation basically asks us to follow "Directive 93/42.
Particularly concerning Part II.
Is my understanding of this correct?
 

dgrainger

Trusted Information Resource
#4
Hi Hiro@162,
Yes, for Great Britain (England, Scotland & Wales) it is MDD/IVDMDD based until 2023.
Northern Ireland is following EU MDR/IVDMDR under the NI protocol.

There are additional requirements around registration, UKCA/UKNI marking and having a UKRP.
 

Hiro@162

Starting to get Involved
#5
Dear dgrainger,

Thank you very much for all your help.
Please tell me one more thing.

Great Britain (England, Scotland & Wales) it is MDD/IVDMDD based until 2023.

If there is any notice or guidance from the UK government that clearly states the above, please let me know the URL.
 
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