Legacy Products - Change in the Legal Manufacturer or EU Representative

somashekar

Staff member
Super Moderator
#11
Re: Legacy Products

I have an interesting extract from our EU rep contract which may be useful here…
The following obligation shall extend at least five years after termination / cancellation of the contract:
Responsibilities of the Manufacturer:In the event that any European authority or national authority or any binding court decision demands from the EU rep access to the Manufacturer’s technical documentation (device-master-files) according to the applicable Annex of the MDD 93/42/EEC or any other applicable national or European law, for devices sold in the EU, the Manufacturer agrees to provide such documentation to the EU rep within three (3) days of the Manufacturer’s receipt of written notification from the EU rep.
 
Elsmar Forum Sponsor

pkost

Trusted Information Resource
#12
Re: Legacy Products

that's interesting to see and doesn't surprise me, although I'm curious that it is limited to five years....implants last considerably longer!
 

somashekar

Staff member
Super Moderator
#13
Re: Legacy Products

that's interesting to see and doesn't surprise me, although I'm curious that it is limited to five years....implants last considerably longer!
Yes. This was specific to the type of class IIa products that appeared in the Annex A.
 
Thread starter Similar threads Forum Replies Date
Q New IVDR and Legacy Products EU Medical Device Regulations 5
S Legacy Products and ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
B Legacy products in an AS9100 QMS precision machining job shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D Legacy Device Review CE Marking (Conformité Européene) / CB Scheme 1
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
Edward Reesor Reassigning GTIN to a legacy device US Food and Drug Administration (FDA) 1
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
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
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
B Identifying AS9100 for a Legacy Product Manufacturing and Related Processes 11
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
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
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
T Document management software - Legacy document approval history Document Control Systems, Procedures, Forms and Templates 3
Q Understanding "free movement" for CE-marked products EU Medical Device Regulations 2
lanley liao How to understand correctly the requirements of API monogram products Oil and Gas Industry Standards and Regulations 0
Judy Abbott The impact of laser power on biocompatibility of the products Manufacturing and Related Processes 6
S Determining the requirements for the products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
M Examples of Combination Products - MDR Article 1 (8) and MDR Article 1(9) Medical Device and FDA Regulations and Standards News 3
M Combination products - examples CE Marking (Conformité Européene) / CB Scheme 1
R Compatibility studies for Combination Products - Europe Medical Device and FDA Regulations and Standards News 2
X ISO 17025 certification for Laboratory for online gambling products ISO 17025 related Discussions 3
A Ethics Committee Review Process for IVD Products EU Medical Device Regulations 2
K AS9100D 8.2.1 Review Requirements for Products and Services AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
P Violation of CE mark - Re-use of single-use Products CE Marking (Conformité Européene) / CB Scheme 2
A Aesthetic products / indication EU Medical Device Regulations 6
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Multiple function device products EU Medical Device Regulations 0
Inggo28 Products Potentially Infected by Covid - 19 Human Factors and Ergonomics in Engineering 1
C Combination Products - Distributor of the device? EU Medical Device Regulations 7
A Can a US manufacturer put export only products on a CFG? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R DFMEA/PFMEA mitigation of high severity (9-10) in low volume products IATF 16949 - Automotive Quality Systems Standard 1
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2

Similar threads

Top Bottom