SBS - The best value in QMS software

MDR - Is a formal GSPR Procedure required?

MakingADifference

Involved In Discussions
#1
Hi.

I was wondering if people have created a GSPR procedure for the MDR? This was a point during an MDR Upgrade Assessment and I was wondering if people had written a formal procedure against this?

I appreciate that we have to provide a checklist as evidence but is a procedure required?

Thanks.
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#5
Perhaps what you can do is add a small section to your existing regulatory compliance procedure that talks about GSPR and add the Form to the reference list.

Shimon
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#7
Perhaps what you can do is add a small section to your existing regulatory compliance procedure that talks about GSPR and add the Form to the reference list.

Shimon
I agree with this approach. It doesn't take much time and can keep any future issues from occurring.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
No 'shall' so not a non-conformance at all. But it doesn't hurt to take a few minutes to 'future proof' against wayward auditors and wasting time going through verbal battle(s) again.
 

pziemlewicz

Involved In Discussions
#10
It doesn't need its own procedure, but it does need to be done. I've referenced GSPR in my Design Control procedure alongside requirements definition.
 
Thread starter Similar threads Forum Replies Date
R MDR Software Rule 11 Formal Interpretation EU Medical Device Regulations 7
A MDR ANNEX XI part A or Part B EU Medical Device Regulations 0
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
U Distributor obligations under MDR EU Medical Device Regulations 1
Raisin picker CECP, consultation according to Art 54 MDR EU Medical Device Regulations 1
K Question on MDR classification EU Medical Device Regulations 4
M STED vs MDR EU Medical Device Regulations 0
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
M Extension to shelf life of new product under MDR EU Medical Device Regulations 1
J Instructions for use for Class I devices under MDR EU Medical Device Regulations 1
K Importer in EU, but not distribute in the EU - MDR obligations EU Medical Device Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Responsibilities of Importers / Distributors - MDR EU Medical Device Regulations 3
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
R EU-MDR Article 9-common specifications Other ISO and International Standards and European Regulations 2
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
P EU MDR Translation of Product Name EU Medical Device Regulations 0
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
K Quality Agreement MDR - The manufacturer is outside of EU Other Medical Device Related Standards 4
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 5
M MDR harmonized standards EU Medical Device Regulations 3
cscalise RAPS/Med Dev EU MDR Guidebook - Reviews or Opinions? EU Medical Device Regulations 0
V New Product Model CE Mark Certification under MDR EU Medical Device Regulations 0
E MDR PRRC "jointly responsible" EU Medical Device Regulations 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 2
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
U EU-MDR: Complicated supply chain EU Medical Device Regulations 4
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
A IVD in MDR procedure pack EU Medical Device Regulations 2
Ed Panek IFU Contact Requirements - FDA and MDD/MDR US Food and Drug Administration (FDA) 1
S Are EC type examinations still being conducted under MDR? EU Medical Device Regulations 5
U MDD Article 12/ MDr Article 22 interpretation EU Medical Device Regulations 2
E MDR internal audit Internal Auditing 1
R The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO Risk Management Principles and Generic Guidelines 4
R MDR, Annex I, 23.1 Interpretation - IFU on the website EU Medical Device Regulations 5
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
S EU MDR CAPA - GAP Assessment on CAPA SOPs EU Medical Device Regulations 1
M MDR Article 22 Interpretation EU Medical Device Regulations 3
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
L EU MDR Article 86 PSUR EU Medical Device Regulations 1
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
S Classification of a product according to MDR EU Medical Device Regulations 3

Similar threads

Top Bottom