EU MDR (GSPR Checklist) consolidated with TGA EP Checklist

M

medwise

Involved In Discussions
#1
#1
Hi Experts,

Can someone please share a gap analysis or a consolidated EU MDR GSPR and TGA Essential Principles checklist?

Thank you.
medwise
 
Download Free White Paper
Elsmar Forum Sponsor
L

lahol

Registered
#5
#5
medwise said:
Hi Experts,

Can someone please share a gap analysis or a consolidated EU MDR GSPR and TGA Essential Principles checklist?

Thank you.
medwise
Click to expand...
Doing a gap analysis yourself should be pretty straightforward since both checklists are publicly available. I'd post links but unfortunately don't have enough posts to do so.

Otherwise I'm sure there are examples on the internet if you do a quick search.
 
R

RA_QA_Expert

Involved In Discussions
#6
#6
Hi, TGA EP are similar to MDD ER. The base is GHTF document. If you did gap analysis between MDD ER a MDR GSPR, you can the results apply also for TGA EP.

The intention is still the same, to have product which is safe, effective and in regulatory compliance, but GSPR are more risk oriented and more specific. If you meet GSPR you yould be in compliance also with TGA EP (if country specific requirement are met).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F MDR GSPR Checklist template EU Medical Device Regulations 9
A MDR GSPR Checklist wanted EU Medical Device Regulations 6
F MDR GSPR 23.4 (c) EU Medical Device Regulations 6
S MDR GSPR Standards EU Medical Device Regulations 1
J EU MDR GSPR 10.4.3 and 10.4.4 EU Medical Device Regulations 2
I Interpretation of the MDR GSPR 23.4 (u) EU Medical Device Regulations 3
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
Rincewind MDR - GSPR - Annex I - Chapter II EU Medical Device Regulations 5
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 21
D Summary of safety and clinical performance in GSPR MDR EU Medical Device Regulations 4
E EU MDR GSPR 23.1 information on website CE Marking (Conformité Européene) / CB Scheme 8
M Clinical evaluation process of FDA and MDR Medical Device and FDA Regulations and Standards News 2
G MDR CE Experation date EU Medical Device Regulations 1
C MDR vs CMDR EU Medical Device Regulations 4
O MDR language requirements EU Medical Device Regulations 12
K Whether the product is an accessory according to the MDR definition EU Medical Device Regulations 3
L Adverse Event Reporting Flowchart (MDR EU) EU Medical Device Regulations 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
Ed Panek MDR Delay? EU Medical Device Regulations 2
dgrainger Informational Proposal to address MDR challenges EU Medical Device Regulations 16
goldenguo MDR/IVDR Insurance and Liability for Manufacturers, EU Representative and Importer EU Medical Device Regulations 3
B MDR PSUR versus Canadian Summary report EU Medical Device Regulations 4
C MDR 2017/744 Article 22 EU Medical Device Regulations 3
K Sales of MDD devices with expired CE that are pending MDR certification EU Medical Device Regulations 4
D New Device Post Market Requirement for MDR EU Medical Device Regulations 3
D EU MDR Derogation EU Medical Device Regulations 0
Doninina Risk management file according MDR or ISO 14971:P2019 ? EU Medical Device Regulations 2
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
A PMSR or PSUR for legacy MDD-class I becoming MDR class-IIa EU Medical Device Regulations 8
H MDR clinical evaluation EU Medical Device Regulations 0
M Possible topic for Master thesis topic - MDR and QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
D MDR technical file: does it need to contain duplicates of controlled documents EU Medical Device Regulations 2
D Does the MDR article 10 (14) needs to be documented word for word in a Procedure? EU Medical Device Regulations 1
N Adding New Products during MDR transition period Manufacturing and Related Processes 1
L Internal Audits during the MDR Transition Period EU Medical Device Regulations 5
Z How to keep up with changes on applicable technical standards (EU MDR)? EU Medical Device Regulations 6
S OEM- Virtual Manufacturer contract MDR Quality Management System (QMS) Manuals 0
J TGA CER & EU MDR CER Requirements for Australia Other Medical Device Regulations World-Wide 3
G MDR DRAFT DoC EU Medical Device Regulations 7
F MDR Distributor EU Medical Device Regulations 6
Y EU MDR Technical Documentation - Defined Review EU Medical Device Regulations 1
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
M Declaration of conformity MDR EU Medical Device Regulations 10
dgrainger Informational Manual on Borderline for MDR/IVDMDR EU Medical Device Regulations 6
G MDR Requirements for Samples EU Medical Device Regulations 5
C Applicability of classification rule 9 under MDR EU Medical Device Regulations 6
H Is testing according to IEC 60601-1 & IEC 60601-1-2 mandatory for a device being registered under MDR? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ed Panek MDR question - Meaning of Stability CE Marking (Conformité Européene) / CB Scheme 6
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
A EU MDR Annex II and Annex III CE Marking (Conformité Européene) / CB Scheme 6

Similar threads

Top Bottom