A

Assists

R

Responsible

P

Preparation

V

Voluntary

            Notified Body

   Sales & Marketing/Shipping

Production/Manufacturing

Research/Design & Development

Management/QMS Representative

1

Manufacturer Information

1.1

Name and address of Manufacturer , name and address of Authorized Representative, all manufacturing locations, (excerpt commercial register or trading license)

RP

1.2

Manufacturer’s EC Declaration of Conformity,

Application or certificates, documentation Quality System

EN ISO 13485

RP

A

1.3

DIMDI Notification according to §§ 25 and 31 MPG and Art. 10 of the Directive 98/79/EC.  Form for certification information of IVD (Annex III to VII of 98/79/EC)

RP

2

Product Description

2.1

Product description including all variations (photographs, advertising material or brochure) as well as a clear definition of the product and its accessories.

R

A

P

2.2

Definition of Intended Use

RP

A

2.3

Classification and Conformity assessment procedure according to IVDD 98/79/EC.

R

P

2.4

Documents delivered/distributed with product:  instructions for use, user manuals, (EN 591, EN 592), installation instructions, service documents, and maintenance instructions.

R

A

P

2.5

Labeling and Information

Labeling of and product information on the IVD product provided to professional users (EN 375)

R

A

P

Labeling of and product information on the IVD product provided for use of product by lay persons (EN 376, EN 13532)

R

A

P

Labeling requirements for IVD Instruments (EN 1658)

R

A

P

Model/makes/serial plates or labels, warnings, symbols used (EN 980, ISO 15223)

R

A

P

A

Assists

Notified Body

R

Responsible

Sales & Marketing/Shipping

P

Preparation

Production/Manufacturing

V

Voluntary

Research/Design & Development

         Management/QMS Representative

2.6

List of standards applied, of Common Technical Specifications (CTS) and proof of fulfillment of essential requirements

(CE essential requirement checklist)

R

P

2.7

Risk analysis and hazard management processes (EN ISO 14971, EN 61010-1-x, EN 13641), including graphs and summary of the risk analysis. Software security

RA

P

A

2.8

Specified combinations with other products (product compatibility), module interfaces

RP

A

3

Product specifications

3.1

List of components, instrument and assembly identification, parts list with manufacturer’s data

R

A

3.2

Device and Component Design: mechanical design, component diagram, circuit/wiring diagram, parts list with approximate X,Y position, electrical layout all layers, instrument assembly instructions, terminal allocation plan/diagram.

RP

A

3.3

Description of components, circuits and functions, alarm scheme, insulation diagram.

RP

A

3.4

Biological and chemical specifications of components

RP

A

3.5

Specifications of other material used

RP

A

3.6

Specifications of substances to be used in reagent/instrument combination

RP

A

3.7

Description of manufacturing procedure, of process validation procedure, of specifications during manufacturing, for example, clean room requirement, production hygiene, of programmer description, instruction/references for distributor/shipping, operation breakdown sheet (including startup/initiation plan), procedure and processes

RP

A

3.8

Production quality assurance measures (inspection plan & procedure, descriptions of in-process verification and final inspection.  Sample of test reports

RP

A

A

3.9

Description of sterilization specifications (EN 552, EN 556) and environment hygiene, process validation

RP

A

3.10

Packaging specifications (EN 868-x, EN 829)

RP

A

A

Assists

Notified Body

R

Responsible

Sales & Marketing/Shipping

P

Preparation

Production/Manufacturing

V

Voluntary

Research/Design & Development

             Management/QMS Representative

4

Product Verification

4.1

Results Inspection and test reports

RP

P

V

4.2

Performance Testing

RP

P

4.3

Results Stability testing /Determination shelf life , product lifetime EN 13640)

RP

(P)

4.4

Construction calculations, justification design results, for example, voluntary design verification, electrical safety test reports, lab testing, validation results

RP

V

4.5

Toxicology and biocompatibility (EN ISO 10 993-8, EN 10993-14, EN ISO 10993-15)

Material certificates, EU safety data form

R

P

V

4.6

Software (DIN EN 60601-1-4), version management,

flow-charts, operating software, program description, software validation, off the shelf software

RP

V

4.7

Electromagnetic test results, certificates

RP

4.8

Proof of fulfillment of safety regulations for electrical, equipment, measuring, drive units and lab instruments (DIN EN 61010-1)

RP

P

4.9

Validation of transport packaging:  test results, expert opinion

R

P

4.10

Proof product works in system combination, with other products.

RP

4.11

Diagnostic reliability testing, diagnostic evaluations, Usability studies, diagnostic studies

RP

V

4.12

Performance evaluation data, EN13612, CTS, NB-Med/2.7/R3 (Draft Oct. 98)  NCCLS Standards, Paul Ehrlich Institute Requirements

RP

4.13

Control and Calibration materials used, Reference measures and system, International standards

PR

4.14

Proof of fulfilling essential requirements when combined with one or more products

PR

A

4.15

Design history file:  Review of product specifications, verification plan/schedule, requirement catalogue, customer requirement specifications, critical parts and components, review  documentation, verification results, time schedules, qualification report prototype, “0” series report, release documents, FMEA, FTA

V