design dossier - · pdf filedesign dossier (dd) ... device master record (dmr) + a dhf...

of 35Rob Packard, President

ww.MedicalDeviceAcademy.comrob@13485cert.com

Class III

Design

Dossier

Class IIbTechnical File

Spinal Implants

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…

Notified Bodies in 2010

http://bit.ly/SelectingRegistrar

The 2013 draft EMDR

Will your Notified Body be “Special”?

http://bit.ly/EMDR‐Frankenstein

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)

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)

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.

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.”

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.

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

Current SpinalRegulatory Pathway

Future SpinalRegulatory Pathway

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

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.

Design & Development

User Needs

Design Input

DesignProcess

DesignOutput

MedicalDevice

VALIDATION

VERIFICATION

REVIEW

Clause 7.3 – “Waterfall Diagram”

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.

Premarket Design Changes• Significant changes pre‐release should have…

– Design Plan change

– Risk Management File change

– IOVV Change

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

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

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?

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)

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

Input OutputVerification Validation

IOVVitem User Needs Design Inputs Design Outputs Verification Test Method Validation Test Method 12345678910

Also called a Design Requirements Matrix (DRM)

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

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?

Design Risk Management Tasks

DHFBegins

ProductLaunch510(k)

Design Transfer

ConceptPhase

FeasibilityPhase

DevelopmentPhase

PilotPhase

ReleasePhase

HazardIdentification

Risk ControlOption Analysis

RiskAssessment

Risk ControlEffectivenessVerification

RiskManagement

PlanRisk / Benefit

Analysis

Risk ManagementReport

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

Starting the Lifecycle Loop

#3 – Clinical Risk/Benefit Analysis

#2 – Post‐Market

Surveillance & Estimation of

#1 – Hazard Identification & Estimation

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

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?

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.

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.

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?

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

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.

Thank you

Hamish Forster Bassil Akrahttp://bit.ly/BZDovGal

http://bit.ly/MyBoneZoneArticles

Rob Packard

rob@13485cert.com

+1.802.281.4381

rob13485

design dossier - · pdf filedesign dossier (dd) ... device master record (dmr) + a dhf...

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