SBS - The Best Value in QMS software

Legacy Device Review

#1
Can someone tell about Legacy Device Review. Is it required as we have MDD certificate valid upto year 2024 for our medical devices.
 
Elsmar Forum Sponsor

swathi.sp

Involved In Discussions
#3
Can someone tell about Legacy Device Review. Is it required as we have MDD certificate valid upto year 2024 for our medical devices.
Hi Dingoel,

Though you have MDD certificate which is valid till 2024, the legacy device requirements of MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place.

As registration of economic operator in EUDAMED is mandate post 26-May-2021 regardless of manufacturer having CE certficate with directive, it is required to get review legacy device as per MDR requirement with your Auth rep to recieve the Mandate and get your SRN as per MDR article 11.

Hope this helps.

Best wishes,
Swathi SP
 
#4
Hi Dingoel,

Though you have MDD certificate which is valid till 2024, the legacy device requirements of MDR relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place.

As registration of economic operator in EUDAMED is mandate post 26-May-2021 regardless of manufacturer having CE certficate with directive, it is required to get review legacy device as per MDR requirement with your Auth rep to recieve the Mandate and get your SRN as per MDR article 11.

Hope this helps.

Best wishes,
Swathi SP
Hi Dingoel, does this still apple since EUDAMED is not ready? Or does it need to be done for EUDAMED.
Also, is it just required before product is placed on the market? What if the product has valid MDD certificate but will not be placed in the EU market for some time.

thank you
 

Raisin picker

Involved In Discussions
#5
Have a look at MDCG 2021-1. It details how to proceed with several tasks now as long as EUDAMED is not available.

And regarding May 2021: MDR is now in force. You have to adhere to everything, for any medical device carrying the CE mark, unless there is an exception in the MDR (e.g. Article 120) or some MDCG document. You should not ask "what does apply to my legacy dedvice", but "what does not yet apply to my legacy device".
 
Thread starter Similar threads Forum Replies Date
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
Edward Reesor Reassigning GTIN to a legacy device US Food and Drug Administration (FDA) 1
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
K Unique Device Identifier for updates to legacy standalone software Other US Medical Device Regulations 1
A DHF (Design History File) for a Legacy Product (Class iii Medical Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Thoughts on validation of Legacy Systems for Medical Device Software EU Medical Device Regulations 2
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
C MDCG 2020-06 Clinical evidence legacy devices EU Medical Device Regulations 3
Z Economic Operators Responsibilities after DOA for legacy MDD devices EU Medical Device Regulations 2
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 10
Q MDR Effectivity date for Legacy Class I Medical Devices EU Medical Device Regulations 5
M Informational MDCG 2019-5 Registration of legacy devices in EUDAMED Medical Device and FDA Regulations and Standards News 11
Marc About These "Legacy Blogs" - 19 November 2018 Imported Legacy Blogs 0
Q New IVDR and Legacy Products EU Medical Device Regulations 5
B Identifying AS9100 for a Legacy Product Manufacturing and Related Processes 11
C Legacy Medical Devices -- RoHS compliance in 2014 or 2019? RoHS, REACH, ELV, IMDS and Restricted Substances 5
G Legacy Product - Do we need follow QSR 820? Design Verification and Validation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
C IEC 62304 conformity for 510k submission legacy product including software IEC 62304 - Medical Device Software Life Cycle Processes 2
C Legacy Products - Change in the Legal Manufacturer or EU Representative EU Medical Device Regulations 12
S Legacy Products and ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
M Process Validation and Qualification of Legacy Equipment ISO 13485:2016 - Medical Device Quality Management Systems 10
A Combination Product - Legacy Drugs and Reclassification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E Legacy Forms - Should Change Control apply to legacy forms? Document Control Systems, Procedures, Forms and Templates 5
K Roh Moo-hyun leaves a legacy shaped by contradiction World News 0
B Legacy products in an AS9100 QMS precision machining job shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T Document management software - Legacy document approval history Document Control Systems, Procedures, Forms and Templates 3
B FDA Breakthrough Device can be overlapped with a designated device? US Food and Drug Administration (FDA) 6
D Add new device to current license Canada Medical Device Regulations 0
S Obsolescence of the Medical Device in Various Countries Other Medical Device Related Standards 0
A IT-NETWORK in PEMS Sub-Clause 14.13 for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
G Medical Device - Borderline/Definition EU Medical Device Regulations 0
B Is labeling on the device itself required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Intended Purpose on device label EU Medical Device Regulations 7
S Medical device equipment calibration Qualification and Validation (including 21 CFR Part 11) 1
P European Medical Device Nomenclature (EMDN) and CND EU Medical Device Regulations 3
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 1
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T CE Marking - Bench mark Device from same manufacturer CE Marking (Conformité Européene) / CB Scheme 2
E Medical device applicability to WEEE Other ISO and International Standards and European Regulations 2
Fjalar Spare parts for discontinued MDD compliant class I medical device EU Medical Device Regulations 4
H Medical Device Label Acceptance Criteria Manufacturing and Related Processes 4
J Calling a medical device a medical device (when it might not be one..) UK Medical Device Regulations 29
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
A How can we change a device trade name in 510(k) summary? US Food and Drug Administration (FDA) 0
N Medical device name in different countries EU Medical Device Regulations 4
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
V Medical Device Literature Translation Software ISO 13485:2016 - Medical Device Quality Management Systems 1
M Are you allowed to reuse the same asset number if the device was replaced? General Measurement Device and Calibration Topics 10
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom