Checklist for MDD to MDR gap analysis

Elsmar Forum Sponsor

Jnks_Meddev

Involved In Discussions
#13
Here's a sample checklist. Can someone explain me the difference between MDR and GSPR checklist? Is it the same?
Thanks,
jnks
Apologies! Just looked at it. Annex I defines the GSPR “General Safety and Performance Requirements” requirements to establishes conformity with MDR.
 
Last edited:

dgrainger

Trusted Information Resource
#14
Don't forget that you need to also check the machinery directive as per Article 1.12:

12. Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1) shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation.
 

Seekingknowledgee

Starting to get Involved
#19
Hi guys, I am very new to this. But I have been handed over the work of converting MDD sop to MDR sop. Can someone please tell me if this is what GAP assessment is?

and please a clear guide for beginners to convert sop.
my career depends on this. Please help. Thanks.
 
Thread starter Similar threads Forum Replies Date
G Essential Requirements Checklist - (MDD 93/42 / EEC) Misc. Quality Assurance and Business Systems Related Topics 2
O MDD 93/42/EEC Checklist during Audit EU Medical Device Regulations 12
S Canada - Essential Requirements Checklist for MDD 93/42/EEC Canada Medical Device Regulations 8
F Combined ER/EP Checklist template that covers both MDD ERs and Australian EPs EU Medical Device Regulations 1
A Auditing Checklist for MDD 93/42/EEU that will cross reference several regulations EU Medical Device Regulations 9
L MDD (Medical Device Directive) Compliance Review checklist wanted EU Medical Device Regulations 9
D MDD 2007/ - Essential Requirement Checklist - Physical and Biological Properties EU Medical Device Regulations 4
P Essential Requirements checklist as per unrevised MDD (MDD 93/42/EEC) EU Medical Device Regulations 7
J Medical Device Directive (MDD) 2007/47/EC and 2006/42/EC EHSR checklist EU Medical Device Regulations 7
T MDD Essential Requirements Checklist in accordance with MDD 2007/47/EC EU Medical Device Regulations 3
I Essential Requirements Checklist for MDD 2007/47 Document Control Systems, Procedures, Forms and Templates 19
W MDD (Medical Device Directive) Essential Requirements Checklist ISO 13485:2016 - Medical Device Quality Management Systems 18
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
F MDR GSPR Checklist template EU Medical Device Regulations 4
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
A MDR GSPR Checklist wanted EU Medical Device Regulations 6
A ISO 10002:2018 Checklist Needed (Complaints Handling) Customer Complaints 5
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
V Generic IATF 16949 Audit Checklist wanted IATF 16949 - Automotive Quality Systems Standard 3
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
V ISO 50001 - looking for a generic checklist Various Other Specifications, Standards, and related Requirements 5
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
vickyva Checklist for Clinical Investigation compliant to EU-MDR EU Medical Device Regulations 4
M MSDS process audit - Can any one give idea for checklist of the same Occupational Health & Safety Management Standards 14
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
D Required Checklist Showing Compliance to IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 11
D What are the important things to keep track of in product audit checklist? Software Quality Assurance 3
M Quality checklist for opening a second location Document Control Systems, Procedures, Forms and Templates 5
M Informational TGA – Essential principles checklist (medical devices) Medical Device and FDA Regulations and Standards News 2
B Free downloadable AS9100D audit checklist ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
M Informational HPRA Brexit Preparedness Checklist Medical Device and FDA Regulations and Standards News 2
Nicole Desouza Contract / Customer Order Review Checklist Needed Manufacturing and Related Processes 12
C Internal Audit - Process Clause Matrix / Audit Checklist ISO 13485:2016 - Medical Device Quality Management Systems 7
G ISO 22442 Supplier Audit Checklist - Medical devices utilizing animal tissues General Auditing Discussions 0
B IEC 62304 - Update Checklist IEC 62304 - Medical Device Software Life Cycle Processes 2
N Comprehensive Compliance Matrix for Internal Audit Checklist Other Medical Device Regulations World-Wide 1
C CMDR Essential (Safety & Effectiveness) Requirements Checklist? Canada Medical Device Regulations 9
S Internal Audit Checklist for Application/Software development IEC 27001 - Information Security Management Systems (ISMS) 1
O How to create robustness checklist from p diagram FMEA and Control Plans 9
D Essential Requirements Checklist for Standalone Software CE Marking (Conformité Européene) / CB Scheme 10
D FDA QSR task checklist based on inspection citations 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Ashland78 IATF 16949 Internal Audit Checklist Manufacturing and Related Processes 11
P IATF checklist for External Supplier Audit IATF 16949 - Automotive Quality Systems Standard 9
CbusQAguy IATF 16949 6.1.2.3 - Contingency Plans Testing Checklist IATF 16949 - Automotive Quality Systems Standard 3
Ajit Basrur Looking for a Design Transfer Checklist 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N Essential requirements checklist needed? ISO 13485:2016 - Medical Device Quality Management Systems 4
R Anyone who can share a checklist for ISO 29134? IEC 27001 - Information Security Management Systems (ISMS) 7
V MAQMSR Checklist Wanted IATF 16949 - Automotive Quality Systems Standard 8

Similar threads

Top Bottom