SBS - The best value in QMS software

The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status

JoshuaFroud

Involved In Discussions
#1
Good Morning Cove

As some of you may be aware Lloyd's Register withdrew its notified body status for MDD and IVDD last month (see link below).

Lloyd’s Register withdraws MDD and IVDD services.

I was interested to know how many of you were impacted and how you are getting on with sourcing a new provider? Does anyone know roughly how many companies this impacted?

The MHRA in the UK has been less than clear with the guidance they have issued around the event which has not helped the situation.
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Interesting. As many people realize, after the PIP breast implant scandal, many organizations working in the Medical Notified Body space are reassessing their continual presence. Liability exposure equations have changed and some conformity assessment organizations don't have a large risk appetite.

In the case of this NB, it is also likely that Brexit might have played a part in the decision making process. Nevertheless, it is interesting to see that (much) heightened oversight of NB's, as an outcome of some highly publicized faux pas, is leading to a significant reduction of NB services providers.

I still wonder if a similar thing would happen in the management system certification sector. As it is, the trivialization and commoditization downward spiral is seriously affecting the intended outcome of providing confidence and trust in the global supply chain.
 
Thread starter Similar threads Forum Replies Date
Ajit Basrur Withdrawal of Audit Report Supplier Quality Assurance and other Supplier Issues 3
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
M Informational EU – Medicinal products and medical devices: Coordinated approach in case of a withdrawal of the United Kingdom from the Union without a deal Medical Device and FDA Regulations and Standards News 0
M Informational EU – Questions And Answers Related To The United Kingdom’s Withdrawal From The European Union With Regard To Industrial Products Medical Device and FDA Regulations and Standards News 0
M Medical Device News Brexit - Withdrawal Agreement and Political Declaration laid before Parliament following political agreement. EU Medical Device Regulations 4
M Medical Device News FDA news 14-09-18 - Recognition and Withdrawal of Voluntary Consensus Standards Other US Medical Device Regulations 2
K Class II Medical Device Compatibility Issue - Removal or Market withdrawal? US Food and Drug Administration (FDA) 2
R ISO 22000:2005 Clause 7.10.4 Withdrawal - Applicability and documentation required? Food Safety - ISO 22000, HACCP (21 CFR 120) 3
P Mock Withdrawal Frequency Food Safety - ISO 22000, HACCP (21 CFR 120) 3
E Withdrawal of ASTM F-745 07 CE Marking (Conformité Européene) / CB Scheme 5
K Product Recall and Withdrawal ? Example procedure wanted Food Safety - ISO 22000, HACCP (21 CFR 120) 7
K Are Withdrawal and Recall a kind of Control of Nonconformity? Food Safety - ISO 22000, HACCP (21 CFR 120) 5
M Market Withdrawal or a Removal? Replace product in the field with an improved version Other US Medical Device Regulations 3
T BRC Audit Finding: Withdrawal/Recall policy - Advice? Food Safety - ISO 22000, HACCP (21 CFR 120) 12
A Lloyd's Register Quality Assurance Out of Registration Business? Registrars and Notified Bodies 7
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
S How to register class IIA medical device accessories EU Medical Device Regulations 1
Tagin Is SARS-CoV-2/COVID-19 on your risk register? Misc. Quality Assurance and Business Systems Related Topics 11
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
K Capturing local government development/planning activities in aspect register ISO 14001:2015 Specific Discussions 2
S Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949 ISO 14001:2015 Specific Discussions 6
L Need to register Medical Devices in Canada (FDA, HC, CMDCAS...) Canada Medical Device Regulations 3
D Design developer - 21 CFR 807 - do we need to register? Other US Medical Device Regulations 0
MrTetris Informational Risk Register - Same hazardous situation, different severity of harms ISO 14971 - Medical Device Risk Management 7
C Do Distributors need to register with competent authorities in the EU? EU Medical Device Regulations 2
A Do I have to register with the FDA and pay fee? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H REACH Registration Requirements - Who is required to Register REACH and RoHS Conversations 1
Z Do we need a Risk Register for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Register of TS 16949 Certified Companies IATF 16949 - Automotive Quality Systems Standard 2
B List of Legislation - Legal Register for ISO14001 ISO 14001:2015 Specific Discussions 3
T ISO 9001:2015 vs AS9100D - Register to one or both Standards? Manufacturing and Related Processes 10
L In Venezuela, do I have to register Molecular diagnostics kits or IVD kits? Other Medical Device Regulations World-Wide 1
B Before new supplier register into ASL ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Get information into English about medical devices register in Serbia Other Medical Device Regulations World-Wide 2
B Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt Other Medical Device Regulations World-Wide 8
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Risk Register template as per ISO 27001:2013 wanted IEC 27001 - Information Security Management Systems (ISMS) 9
C Should we register to ISO 9001:2008 or ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Do I need to Register with FDA? How shall my structure of processes look like? US Food and Drug Administration (FDA) 4
N How to register a non notified Medical Device in India Other Medical Device Regulations World-Wide 5

Similar threads

Top Bottom