Using MDD Annex III + V Conformity Assessment Pathway

Sam Lazzara

Trusted Information Resource
#1
I have only used MDD Annex II (Full quality assurance system) to obtain CE marking.

Any experience with using Annex III (EC-Type Examination) combined with Annex V (Production quality assurance)?

Advantages? Disadvantages?

Any differences between thresholds for having to submit a Change Notice to the Notified Body when using Annex III as compared to Annex II?
 
Last edited:
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
I have only used MDD Annex II (Full quality assurance system) to obtain CE marking.

Any experience with using Annex III (EC-Type Examination) combined with Annex V (Production quality assurance)?

Advantages? Disadvantages?

Any differences between thresholds for having to submit a Change Notice to the Notified Body when using Annex III as compared to Annex II?
Hi Sam,

I also never went through certification to annex III+V. My impression, based on discussions with peers, manufacturers and NB staff, is that annex III certification has the following (serious) downsides:

1. Initial certification might involve lengthy and expensive testing by the NB (or outsourced by the NB).

2. Every significant change of the device, post-certification, must be communicated with the NB, and might trigger another round of lengthy and costly examination and testing.

Regarding notification of "significant changes" of the QMS, I'm not aware of the threshold being different for annexes II and V.

Cheers,
Ronen.
 

RobertvanBoxtel

Involved In Discussions
#3
Hi Sam,

Please refer to http://www.nbog.eu/resources/NBOG_BPG_2014_3.pdf for a comparison on notification requirements between Annex II and Annex III/V.

In case you are a start-up with only one device type, Class III, in practice there is no difference in the post CE phase regarding notification. To obtain CE marking, the Notified Body might require witness testing or perform it's own testing conform Annex III. Or they will review the documents of testing done, depending on the NB. As a start-up, it is sometimes difficult to cover all the requirements of Annex II and expectations of NB's related to Annex II. IF during the Design Dossier review many questions are to be answered that demonstrate that Annex II is not really understood and covered by the manufacturer, the NB can decide not to issue Annex II and Annex II.4 certificates, but allow the product on the market (after answering all questions adequately) under Annex III/V.

For the situation above, if your device is Class IIb, the initial assessment under Annex II will not be much different (again in practice), but once in the market, you have less prior approval requriements. Under Annex III/V those still exist as described above.

Greetings, Robert
 
Thread starter Similar threads Forum Replies Date
L CE Auditor Using ISO audit reports to show compliance to the MDD?? EU Medical Device Regulations 4
J Incoming Inspection Records using Excel File ISO 13485:2016 - Medical Device Quality Management Systems 2
J Using ring gauges General Measurement Device and Calibration Topics 2
M Load Cell Calibration using a totalizer on a flow meter General Measurement Device and Calibration Topics 0
P Can Neoprene be Cleaned Using Isopropyl Alcohol (IPA) Manufacturing and Related Processes 4
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
chris1price Sterilization using beta radiation Other Medical Device Related Standards 2
M Using the phrase "herein referred to" Document Control Systems, Procedures, Forms and Templates 8
B Struggling with using the 5.6 version Ford Capacity Analysis Report APQP and PPAP 5
cnbrosa Study Type 1 on a CMM using a measuring support Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R MRB (Material Review Board) Process using MS Sharepoint or MS Teams Manufacturing and Related Processes 2
K 510k FDA review, will they accept Biocompatibility result generated using feasibility product lots? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
B AS9100D 7.1.5.2 Calibration or Verification Method using outside cal lab AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
D Calibration tolerance question using Pipettes Medical Device and FDA Regulations and Standards News 1
D Risk Analysis using Monte Carlo Simulation instead of Scoring and Heat Map Risk Management Principles and Generic Guidelines 2
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
C Importer shell game - Using a third party logistics provider (3PL) in the EU EU Medical Device Regulations 5
S Work performed in Canada on US patients using US device Canada Medical Device Regulations 1
S Is using ANSI/ASQ Z1.4-2008 the correct sampling plan to determine Pass/Fail of Apparel measurements? AQL - Acceptable Quality Level 4
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
Tagin Evaluating nonconformances for escalation using Bayesian methods? Statistical Analysis Tools, Techniques and SPC 2
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
R Clause 7.7 Replicate, Recalibration and Intermediate checks using Artifact ISO 17025 related Discussions 1
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
A Using Arduino based sensors for Poke-Yoke Manufacturing and Related Processes 6
M Using your Manufacturer's ISO certification ISO 13485:2016 - Medical Device Quality Management Systems 5
Ed Panek Adverse Event Clinical Trial using a 510K approved Device Other US Medical Device Regulations 6
B Using non CE parts in a machine CE Marking (Conformité Européene) / CB Scheme 1
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
A Hospital IT expectations for connected medical device using WIFI Medical Information Technology, Medical Software and Health Informatics 0
Proud Liberal Cp / Cpk on position using multiple MMC bonuses Capability, Accuracy and Stability - Processes, Machines, etc. 2
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
D Using "Particle Size Standard" templates as gauges - How to avoid giving a gauge # while using for process control? General Measurement Device and Calibration Topics 2
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
I Reducing CE marking cost using manufacturer test reports CE Marking (Conformité Européene) / CB Scheme 5
CPhelan Using clinical trial safety data for evidence for CE marking EU Medical Device Regulations 8
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
M Raw stock material testing discrepancy using an XRF (x-ray fluorescence) analyzer Manufacturing and Related Processes 7
Z Using FMEA for Knowledge Management FMEA and Control Plans 6
Sidney Vianna NASA to Develop a Novel Approach for All-Electric Aircraft Using Cryogenic Liquid Hydrogen as Energy Storage World News 2
S How many of you are using Robotic process automation for calibration lab management? ISO 17025 related Discussions 0
J Including Repeats in DoE using Minitab Using Minitab Software 5
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
John Predmore What size pinhole can be reliably detected using visual inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7

Similar threads

Top Bottom