SBS - The best value in QMS software

IVDR and MDR ANNEX I Requirements Template

J

jerryz

jzsn
#1
#1
The Annex I of new regulations appear to be the new version of Annex I Essential Requirements in the directives. I wonder if there is any template out there created like the Essential Requirement Checklist?
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
J

jiligan

Involved In Discussions
#2
#2
jerryz said:
The Annex I of new regulations appear to be the new version of Annex I Essential Requirements in the directives. I wonder if there is any template out there created like the Essential Requirement Checklist?
Click to expand...
Hi jerryz, I was wondering if you ever found the template you were looking for? If so could you please share with me? thank you!
 
T

twanmul

Involved In Discussions
#3
#3
I'm not sure why you're not able to take your existing Essential Requirements Checklist and paste in the requirements from the Annex of the Regulations to create a GSPR checklist? This seems like an easy enough thing to do.

If you're just after one that you can use from scratch, then I don't know why you don't just google "General Safety Performance Requirements checklist template." One would come up.

If you're after which requirements under the ER map across to the GSPR, then BSI have a good guide on this (I can't link but just search for GSPR on the BSI site) within its Annex for the MDR. There isn't any guidance I can find for the IVDR.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
Watchcat MDD, MDR/IVDR, Working Groups, Expert Panels, MEDDEVs and Other EU Guidances EU Medical Device Regulations 32
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay Medical Device and FDA Regulations and Standards News 3
M Informational EU – MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a “person re Medical Device and FDA Regulations and Standards News 7
M Informational Medtech Europe presentation – – Industry Perspective on the Implementation Status of the MDR/IVDR Medical Device and FDA Regulations and Standards News 0
M Informational EU MDR and IVDR Factsheet for healthcare professionals and health institutions Medical Device and FDA Regulations and Standards News 0
M Informational From RAPS – UK NB Will Not Apply for EU MDR/IVDR Medical Device and FDA Regulations and Standards News 11
M Informational Next meeting of the Medical Device Coordination Group (MDR/IVDR) – 20 June 2019 Medical Device and FDA Regulations and Standards News 2
M Informational EU – Corrigenda for MDR and IVDR published in Official Journal Medical Device and FDA Regulations and Standards News 0
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
M Medical Device News EU – Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) – infographics Medical Device and FDA Regulations and Standards News 0
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
M Informational Manufacturer Incident Report (MIR) for Serious Incidents (MDR/IVDR) and Incidents (MDD/IMDD/IVDD) Medical Device and FDA Regulations and Standards News 5
M Medical Device News New guidance sheets for the MDR/IVDR published EU Medical Device Regulations 0
M Medical Device News MDR and IVDR implementing measures rolling plan EU Medical Device Regulations 0
bio_subbu CAMD published FAQs to the transitional provisions of MDR and IVDR EU Medical Device Regulations 0
M MDR and IVDR to be published May 5th 2017 EU Medical Device Regulations 14
S MDR & IVDR Introduction in late May 2017 EU Medical Device Regulations 1
M IVDR and Performance Evaluation Plan CE Marking (Conformité Européene) / CB Scheme 2
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
M Informational BSI UK notified under the IVDR Medical Device and FDA Regulations and Standards News 2
M Informational EU – First IVDR designated Notified Body – DEKRA Certification GmbH Medical Device and FDA Regulations and Standards News 0
V CE Mark under MDD or IVDR - IVD company doing Virtual Manufacturing Other Medical Device Regulations World-Wide 3
M Informational Corrigendum for the EU IVDR Published Medical Device and FDA Regulations and Standards News 0
Z UDI assignment Criteria Software IVDR Other Medical Device Regulations World-Wide 0
M Medical Device News Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation – Regulation (EU) 2017/746 Medical Device and FDA Regulations and Standards News 0
Q New IVDR and Legacy Products EU Medical Device Regulations 5
S EU MDR Annex I Chapter III 23.4 z EU Medical Device Regulations 0
R MDR & depth of review by NB's EU Medical Device Regulations 7
U EU-MDR: complicated supply chain EU Medical Device Regulations 0
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 Medical Device and FDA Regulations and Standards News 0
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
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 1
S Classification of a product according to MDR EU Medical Device Regulations 3

Similar threads

Top Bottom