SBS - The Best Value in QMS software

Difficulty Finding A Notified Body for CE Marking - No Capacity


Starting to get Involved
Edit: medical devices

We are having difficulty finding a notified body that is willing to accept our product(s) for CE marking purposes, due to lack of capacity. Our company is based in London, and would prefer to use a NB located close by (though, we are willing to go farther afield if circumstances dictate). I would like leads and recommendations for NBs that might be able to help. UK or Europe.

Elsmar Forum Sponsor


Involved In Discussions
Good Morning Shonver, it may be worth waiting until the Brexit fiasco has resolved itself before choosing your notified body.

Without getting too political, in the event of a no deal, all UK notified bodies for CE marking will cease to be able to grant CE marks as UKAS will no longer be recognised and as such a NB based in Europe will be required.

If there is a deal that deal is likely to include provision for UKAS to still be recognised and UK NB's to continue operation granting CE marks.

So my suggestion would be to wait 20 days or so for the dust to settle into whatever there is left for it to settle to and consider your options at that point.


Starting to get Involved
Good Morning Shonver, it may be worth waiting until the Brexit fiasco has resolved itself before choosing your notified body.
I appreciate your very valid advice. I still have the problem, though, because the capacity issue extends to Europe. If I can at least find a NB with capacity, that will be more than I have right now.

Edward Reesor

Trusted Information Resource
A year or so ago, I was on a webinar on the new MDR, where they gave the number of NB's that left the market. The numbers were astonishing (dropped by half), however it was worse was that they recognized that the number would drop further. I believe the number was 25-30% of the original number. It was felt that this was the price of public safety. Our NB left the market and instead of finding a new one, we withdrew from the market altogether. We experienced something similar in Canada when MDSAP became mandatory and many US and European based companies chose to leave the Canadian market.


Starting to get Involved
Has anyone had any luck with available Notified Bodies taking new clients? We are in the same boat as Shonver.
And are awaiting CE Marking for UK.
Thread starter Similar threads Forum Replies Date
Q Is that any difficulty to do software DFMEA and PFMEA in ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
I Difficulty with calculated t-value for Linearity Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 7
A IMDS DIFFICULTY: Our customer requires the Wildcard portion MUST be < 0.1 % RoHS, REACH, ELV, IMDS and Restricted Substances 5
P Difficulty in Detecting Within Lot Variation when using Zbar W (Normalize) Chart Statistical Analysis Tools, Techniques and SPC 14
M Difficulty in demonstrating Compliance to Many EMC Standards specified! Other Medical Device Related Standards 9
I Difficulty in creating a Quality Manual Quality Management System (QMS) Manuals 4
C 5S - Difficulty in Standardization Lean in Manufacturing and Service Industries 11
Wes Bucey "In the middle of difficulty lies opportunity." - Einstein Career and Occupation Discussions 2
Antonio Vieira Difficulty ?passing? Quality audits - Number of Major / Minor Nonconformances Allowed General Auditing Discussions 12
S Training Evaluation Form - Evaluator feel difficulty to fill this form Training - Internal, External, Online and Distance Learning 12
J CQE Study Guide Indicative of Test Difficulty? Professional Certifications and Degrees 1
J Difficulty with cell phone reception in House with Aluminum Siding Coffee Break and Water Cooler Discussions 23
D Organisational Structure - Difficulty with a business stream approach Misc. Quality Assurance and Business Systems Related Topics 4
B Oil/water separators - Difficulty meeting state wastewater standards Miscellaneous Environmental Standards and EMS Related Discussions 4
S QOS for Tooling and Equipment - Having difficulty selecting a measurable QS-9000 - American Automotive Manufacturers Standard 2
R Using R package to implement Bayesian phase I/II dose-finding design for three outcomes ISO 13485:2016 - Medical Device Quality Management Systems 6
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 10
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
A Define timeline for Major and Miner Audit finding General Auditing Discussions 4
F Closing a finding before closing meeting General Auditing Discussions 14
J Audit Finding For Not Retaining Test Results ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A OHSAS 18001 external auditor finding personal interpretation? Occupational Health & Safety Management Standards 5
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months) should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
Marco Bernardi Finding a flat or not modeling distribution: how to manage it? Capability, Accuracy and Stability - Processes, Machines, etc. 24
H Looking for Tips on finding an IATF consultant Consultants and Consulting 6
D Customer Audit Finding ISO13485:2016 7.6 ISO 13485:2016 - Medical Device Quality Management Systems 7
B PED 2014/68/EU - Is this Traceability audit finding correct? Other ISO and International Standards and European Regulations 4
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
G Audit finding - Components being transferred inter-plant Internal Auditing 3
D AEA (Aerospace Experience Auditor) Challenges - Finding availability of AEA for witness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B IATF 16949 FAQ #7 Audit Finding - External Calibration Laboratory IATF 16949 - Automotive Quality Systems Standard 7
P Major Finding Elevation - Do I elevate this minor finding to a major one? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
S GM/VP softgrading internal audit finding - need feedback from an audit guru! General Auditing Discussions 11
Q Customer Requirements - AS9120B Audit Finding AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 24
J IATF 16949 registration - Major Nonconformance Finding IATF 16949 - Automotive Quality Systems Standard 9
J Hardness inspection Audit Finding Employee error Nonconformance and Corrective Action 6
J How long should I have to correct an audit finding? VDA Standards - Germany's Automotive Standards 7
AlienraverX How to appeal a major audit finding ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
T Non-addressed Minor Finding elevated to Major Finding Internal Auditing 37
S Definition Would a wrong definition constitute an Audit Finding? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
L Audit Finding Flowchart for Feedback General Auditing Discussions 6
B Finding a Fixture Design Course to meet Customer Requirements General Measurement Device and Calibration Topics 3
A Audit Finding - CAPA, Improvement Initiatives not filed in CAR System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O CFDA (China Food and Drugs Administration) Audit Finding Classifications China Medical Device Regulations 1
B Expired Materials (threadlocker) Audit Finding Classification? Internal Auditing 1
S Is not training to ISO 9001 procedures a finding? General Auditing Discussions 16
S Could I issue major finding for Inadequate Procedures Supplier Quality Assurance and other Supplier Issues 17
S Finding a substantial Equivalent Medical Device Other US Medical Device Regulations 4
H Cause analysis for an Audit Finding - Purchasing Procedure Content ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom