design dossier - omtecexpo.com · device master record (dmr) + a dhf (design ... regulatory...
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Slide 1 of 35Rob Packard, President
Class III
Design
Dossier
&
Class IIbTechnical File
Spinal Implants
Slide 2 of 35Rob Packard, President
Why Reclassify?• Metal‐on‐Metal (MoM) Hip implants that were CE Marked prior to the 2007 reclassification resulted in global recalls by multiple companies. Where’s the big catastrophe with spinal implants?
• Most spinal implants achieve fusion with 12‐24 months, but the EU Commission is still pushing for reclassification…
Slide 3 of 35Rob Packard, President
Notified Bodies in 2010
http://bit.ly/SelectingRegistrar
Slide 4 of 35Rob Packard, President
The 2013 draft EMDR
Will your Notified Body be “Special”?
http://bit.ly/EMDR‐Frankenstein
Slide 5 of 35Rob Packard, President
Technical File (TF)• There is no definition of a Technical File (TF), but in layman’s terms it is the Technical Documentation required for Class I, IIa and IIbmedical devices.
• The TF is the most current version.• In fact, the phrase “Technical File” is not used in the MDD (i.e. – 93/42/EEC)
Slide 6 of 35Rob Packard, President
Design Dossier (DD)• The term is only used once in Annex II.4 of the MDD. In layman’s terms, the Design Dossier is the Technical Documentation plus a summary of the history of design changes for the device.
• Equivalent to the US FDA’s requirements for a Device Master Record (DMR) + a DHF (Design History File)
Slide 7 of 35Rob Packard, President
Is there a difference?“In theory there should be little difference.”• I interviewed Hamish Forster at BSI. He has been an orthopedic technical reviewer at BSI since 2007 and he has written some articles for BONEZONE.
• I interviewed Bassil Akra at TÜV SÜD. He is the Manager ‐ IMC / Clinical Affairs.
Slide 8 of 35Rob Packard, President
Three Critical Differences• Summary of history of design changes is required vs. just the current design.
• Notified Body must approve 100% of Significant Changes Prior to Implementation.
• Notified Body will Scrutinize Each Document more Carefully.– “…the typical review time devoted to a design dossier is “at least double” the time spent on the review of Class IIb technical files.”
Slide 9 of 35Rob Packard, President
CE Certificates• Annex II.3 – Full Quality Assurance Certificate• Annex II.4 – Design Examination Certificate• Annex III – Type Examination Certificate• Annex V – Production Quality Assurance Certificate
Note: Do not confuse with your ISO 13485:2003 certificate for the Quality Management System.
Slide 10 of 35Rob Packard, President
Conformity Assessment• The following table summarizes the most popular options for each Device Classification.
Class INon‐measuring / Non‐Sterile
Class IMeasuring/ Sterile
Class IIa Class IIb Class III
Annex VII Annex II or Annex III + V
Annex II or Annex III + V
Annex II or Annex V
Annex II or Annex V
Current SpinalRegulatory Pathway
Future SpinalRegulatory Pathway
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Strategic Planning• Do not combine product families & brands
– Multiple IOVV– Multiple CER– Multiple RM Files– Multiple PMS Plans
• Are you developing new products that will replace the current products?
• Are all your products popular in Europe?• Strategic product portfolio review is needed
Slide 12 of 35Rob Packard, President
Design Master Files• If you have…
– coating process– proprietary alloy or plastic– some other material that is unique to your company
…you might consider creating a design master file that can be referenced by all the other Design Dossiers.
Slide 13 of 35Rob Packard, President
Design & Development
User Needs
Design Input
DesignProcess
DesignOutput
MedicalDevice
VALIDATION
VERIFICATION
REVIEW
Clause 7.3 – “Waterfall Diagram”
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Design Changes
Design Dossiers require a critical review of ALL Design Changes—including pre‐approval of labeling changes and line extensions.
“What may initially be perceived as a small incremental change can lead to significant changes in safety and performance which do require a review.”
– Royal College of Surgeons of England ReportJ Bone Joint Surg [Br] 1997; 79‐B:603‐8.
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Premarket Design Changes• Significant changes pre‐release should have…
– Design Plan change
– Risk Management File change
– IOVV Change
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Post-market Design Changes• Post‐Release significant changes require Design Dossier Supplements
• See NB‐MED/2.5.2/Rec2 rev 7 http://bit.ly/ReportDesignChanges
Slide 17 of 35Rob Packard, President
Essential RequirementsEssential Requirements are part of the technical file or design dossier:• Are set in Annex I• Require the manufacturer to:
– Define fitness for purpose– Perform risk / benefit analysis– Determine their product’s safety– Choose voluntary standards to use as a tool
• A procedure is recommended to provide instructions for completing all required information.
http://bit.ly/NewERCTemplate
http://bit.ly/NewERCGap
Slide 18 of 35Rob Packard, President
ERC Pitfalls• ISO 62366 – Usability• EN ISO 14971:2012 – Risk Management• Animal Tissues – ISO & MEDDEV• Sterilization Validation & Revalidation – ISO• ISO 10993‐1 – Biocompatibility• Applicability to Women & Children• Shelf‐life testing…including storage conditions• Risk of Re‐use
– can you prove the device can’t be re‐used?
Slide 19 of 35Rob Packard, President
Content & Format• CE Marking of medical devices requires technical documentation in accordance with Annex II (i.e., – a Technical File or Design Dossier)—based on the device classification.– NB‐MED 2.5.1/Rec5 rev 4– (http://bit.ly/NBMED251Rec5) – GHTF SG1/N011:2008 (http://bit.ly/GHTFSTEDGuidance)
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A declaration of conformity is (DoC) is the manufacturer’s statement of conformity with a specific assessment process. This must be in accordance with proposed Annex III. It is the manufacturer’s claim that: Product satisfies essential requirements Conformity assessment completed, if required Products are designed, manufactured, and tested in
accordance with technical documentationIt is issued on the manufacturer’s own authority and is a legal document. A copy may be requested by your customers.
Declaration of Conformity
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Input OutputVerification Validation
IOVVitem User Needs Design Inputs Design Outputs Verification Test Method Validation Test Method 12345678910
Also called a Design Requirements Matrix (DRM)
Slide 22 of 35Rob Packard, President
Best Practice Examples• User Need = Implant must fit expected range of adult patient anatomy
• Input = ISO/IEC 62366:2007, Application of usability engineering to medical devices
• Output = Tabulated drawing showing 10 different sizes
• Verification = In silico analysis of fit between patient anatomy and different sizes
• Validation = cadaver studies and clinical studies
Slide 23 of 35Rob Packard, President
Is V&V State-of-the-Art?• Is your risk management documentation compliant with EN ISO 14971:2012?
• If your product is Ethylene Oxide Sterilized, did you perform extractions in accordance with ISO 10993‐7:2008?
• If your product uses UHMWPE, did you evaluate the impact of oxidative degradation in accordance with the latest ASTM standards?
Slide 24 of 35Rob Packard, President
Design Risk Management Tasks
24
DHFBegins
ProductLaunch510(k)
Design Transfer
ConceptPhase
FeasibilityPhase
DevelopmentPhase
PilotPhase
ReleasePhase
HazardIdentification
Risk ControlOption Analysis
RiskAssessment
Risk ControlEffectivenessVerification
RiskManagement
PlanRisk / Benefit
Analysis
Risk ManagementReport
DR
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Risk Management / Design Controls• Clause 7.3.2e) of ISO 13485 states that Risk management shall be an Input into Design & Development
• Clause 6.3 of ISO 14971 requires verification of effectiveness of risk controls
• Clause 6.7 of ISO 14971 requires verification of completeness of risk controls
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Starting the Lifecycle Loop
#3 – Clinical Risk/Benefit Analysis
#2 – Post‐Market
Surveillance & Estimation of
P2
#1 – Hazard Identification & Estimation
of P1
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Maintaining the Lifecycle Loop
#2 – ClinicalEvaluation
#1 – Post‐Market
Surveillance
#3 – RiskAnalysis
Post‐Market Surveillance (PMS) Report, Including Complaints, Measure Frequency of Harm
Clinical Evaluation Report (CER) Is Updated to Verify the Clinical
Risk/Benefit Based Upon PMS Report
Risk Analysis is Updated with Actual data for the Frequency of Occurrence
for Harm
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Is PMCF Required?• MEDDEV 2.12/2 rev 2 (January 2012)
– http://bit.ly/PMCFMEDDEV
• 93/42/EEC; Annex X, 1.1c
• Do you have enough clinical history?• Does your clinical data cover the entire product range?
• Have there been any changes since the clinical study?
• Is the device still considered state of the art?
Slide 29 of 35Rob Packard, President
Importance of Registries• There are national registry databases, but company sponsors are critical for two reasons:
1. Database has detailed information about each variant.
2. Database includes pain and physical function of the device, while national registries typically have only the survivorship data.
Slide 30 of 35Rob Packard, President
Clinical Evaluation Weaknesses• MEDEV 2.7.1 rev 3 is the Requirement• ISO 14155:2011 should be considered for your own clinical studies as State‐of‐the‐Art for clinical study design…is your study from 2008 adequate?
• If you did a literature search, did you include a copy of the search protocol? Did you identify why you selected certain search databases?
• Failure to evaluate the data quality and rank clinical data in the literature is a common finding.
Slide 31 of 35Rob Packard, President
CER Weaknesses (continued)
• Equivalence should not be based upon just one device…you should perform this equivalence analysis after you have performed a thorough literature search.
• Many companies make the conclusion that the clinical benefits outweigh the risks, but they fail to explain how.
• Is the CER author(s) and reviewer(s) qualified?
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Quality Plan Timeline
GapAnalysis
Updating Procedures
Review Phase DD Review by SNB
ScheduleDD Review
w/ SNB TrainEmployees
DesignExamination
Certificate
Internal Auditof Design Dossier
Revision of Technical Documentation
InitialReview
ProjectBegins
Review ofResponses
Initial ReviewerQuestions
Slide 33 of 35Rob Packard, President
Call to Action1. Update your harmonized standards list for
each product family.2. Perform a thorough gap analysis of each file
and against the updated harmonized standards.
3. Perform a strategic portfolio review as suggested in slide 13.
Slide 34 of 35Rob Packard, President
Thank you
Hamish Forster Bassil Akrahttp://bit.ly/BZDovGal
http://bit.ly/MyBoneZoneArticles
Slide 35 of 35Rob Packard, President
Rob Packard
+1.802.281.4381
rob13485
Q & A
