Changes to an already certified product (IIb, MDR)

Asia78

Involved In Discussions
#1
Hi all,
iDd I understand correctly that everytime that there is a change on an already certified product (IIb, MDR) with the change having an impact on safety and performance, the NB needs to assess the change before implementation?
How will it work with the recertification of that device? Will the manufacturer have to pay for the Assessment and then will receive the updated certificate? The basic udi-di will be indeed different... Thanks
 
Elsmar Forum Sponsor

Asia78

Involved In Discussions
#2
Hi all,
iDd I understand correctly that everytime that there is a change on an already certified product (IIb, MDR) with the change having an impact on safety and performance, the NB needs to assess the change before implementation?
How will it work with the recertification of that device? Will the manufacturer have to pay for the Assessment and then will receive the updated certificate? The basic udi-di will be indeed different... Thanks
I read it again and the requirement is only for class III and IIb implantable, at least this is what I see reading Annex IX Chapter II :)
 
Thread starter Similar threads Forum Replies Date
thisby_ Changes in an already certified IEC 60601 Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Making changes to IDE device Other US Medical Device Regulations 7
M MD Class I transition period MDD to MDR - changes? EU Medical Device Regulations 1
S IATF 16949 - Summary at a glance Clause wise - changes from ISO TS IATF 16949 - Automotive Quality Systems Standard 4
M Handling design changes with use-as-is inventory disposition Quality Manager and Management Related Issues 6
S Class 1 and 2 changes in CM standards (aerospace industry) Federal Aviation Administration (FAA) Standards and Requirements 0
S Class 1 vs Class 2 changes Federal Aviation Administration (FAA) Standards and Requirements 0
P Interim Order Authorization Changes Canada Medical Device Regulations 0
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
F Hospital Rebrand & Name changes Document Control Systems, Procedures, Forms and Templates 4
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
NDesouza When Customers Make Changes to Orders Contract Review Process 24
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
R What are the changes in 5th Edition of FMEA manual? FMEA and Control Plans 6
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
M What are the changes in supervising according to ISO17025? ISO 17025 related Discussions 7
U Changes to Internal Processes and Risk Evaluation - Mitigations Risk Management Principles and Generic Guidelines 10
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
R Rationale for changes to ISO Standards Other Medical Device Related Standards 4
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
I Tracking Protoype Changes; 8D or simple document revision? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C What if the foreign manufacturer of a medical device changes the Authorized Representative in Saudi Arabia? Other Medical Device Regulations World-Wide 0
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
J Ethicon suture box design changes - 2019 Other Medical Device Regulations World-Wide 2
E Changes to medical device submitted through a variation? EU Medical Device Regulations 1
T AS9100 Maintain Approval When Business Ownership Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
S ISO9001:2015 6.3 - Planning of Changes - OFI from auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
S Ballooned Drawings and Engineering Changes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
supadrai Changes to QMS - Contract Term ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 9001:2015 6.2 - Planning Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Significant Organizational Changes - Documented Responsibilities Document Control Systems, Procedures, Forms and Templates 4

Similar threads

Top Bottom