Office and manufacturing site relocation effect on Device Technical File

MedicalResp

Starting to get Involved
Hi all,
Hoping to pick your brains (and experience) :

Our company has CE marking under MDD (class IIb) that is valid until 2024.
We relocated our office and manufacturing site to another location within the same city.
We are preforming a complete process validation (IQ,OQ,PQ) in the new facility.
We have already notified our Notified Body and they requested:
1) A review of the Technical File.
2) Phase 1 (Documentation review Address Change : QMS + TF): Off-site Evaluation of Quality System Documents, Procedures and their application in reference to the Medical Device (s) object of the CE Certification
3) Onsite audit at the next surveillance audit.

I understand the NB requirement to review the QMS changes, the new process validation reports and the IFU and labels, but I do not understand their requirement to fully review again the Technical File.
Is this legtimate requirement? Also, in that case, must we update the new address in design validation reports and certificates preformed 2 years ago by external labs (e.g. IEC/EN 60601-X) ?

On a similar topic:
my understanding is that an address change is considered an administrative and "not-significant change" under the MDR (MDCG 2020-03) and that a CE certificate under MDD shall remain valid if the change is not significant. So hypothetically, if we relocate again to a new facility after May 26, 2021 , could the NB review again the the QMS and technical file and issue us a revised CE certificate with the new address or would there a clash with MDR Article 120 ?

Thanks in advance
 

J0anne

Joanne
Hi all,
Hoping to pick your brains (and experience) :

Our company has CE marking under MDD (class IIb) that is valid until 2024.
We relocated our office and manufacturing site to another location within the same city.
We are preforming a complete process validation (IQ,OQ,PQ) in the new facility.
We have already notified our Notified Body and they requested:
1) A review of the Technical File.
2) Phase 1 (Documentation review Address Change : QMS + TF): Off-site Evaluation of Quality System Documents, Procedures and their application in reference to the Medical Device (s) object of the CE Certification
3) Onsite audit at the next surveillance audit.

I understand the NB requirement to review the QMS changes, the new process validation reports and the IFU and labels, but I do not understand their requirement to fully review again the Technical File.
Is this legtimate requirement? Also, in that case, must we update the new address in design validation reports and certificates preformed 2 years ago by external labs (e.g. IEC/EN 60601-X) ?

On a similar topic:
my understanding is that an address change is considered an administrative and "not-significant change" under the MDR (MDCG 2020-03) and that a CE certificate under MDD shall remain valid if the change is not significant. So hypothetically, if we relocate again to a new facility after May 26, 2021 , could the NB review again the the QMS and technical file and issue us a revised CE certificate with the new address or would there a clash with MDR Article 120 ?

Thanks in advance

Yes it will need to be reviewed to ensure all the labelling and any QMS documentation has been updated to reflect the new address
 

MedicalResp

Starting to get Involved
Yes it will need to be reviewed to ensure all the labelling and any QMS documentation has been updated to reflect the new address
As I wrote, I understand the need to review lables and IFU, but why to review all the TF ? Also, I am not sure if in this case, we must update the new address in design validation reports and certificates preformed 2 years ago by external labs (e.g. IEC/EN 60601-X) .
 
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