Design dossiers are technical files for class III devices and comprehensively examined by the Notified Body.

1. Med-Info
Regular Information Bulletins for the Medical Device Industry Product Service
Design Dossiers
Design dossiers are technical files for class III It is recommended to compile a Design
devices and comprehensively examined by the Dossier or Technical File as follows
Notified Body. (see also NB-MED/2.5.1 and GHTF document
SG1 (PD)/N011R20: STED):
Medical Device Directive (MDD) Annex II
Section 4.2 states that an application for PART A: Technical File
examination of the design of the product must
include the documents needed to assess 1. Table of Content
whether the product conforms to the
requirements of the MDD. 2. Introduction
Design dossiers have to be submitted to the • Revision history of Design Dossier
Notified Body for review prior to CE marking of • Regulatory information, e.g. classification
the product. We will assign a project manager of the device including the product code
who will entrust one or more further experts with according to the Universal Medical Device
the review of particular modules. All experts are Nomenclature System and/or Global Medical
at your disposal directly or indirectly through the Device Nomenclature (UMDNS, GMDN)
project manager. After successful review, the • Brief description of the product: intended use,
Notified Body issues a design examination model numbers and names, variants,
certificate according to Annex II.4 of the Council accessories, list of accessories or equipment
Directive 93/42/EEC certifying compliance with intended to be used in combination with the
the relevant provisions of Annex I of the MDD. device, applied standards, etc.
• History of the device: market release, items
Product documentation sold, history of the materials used, change
• According to MDD Article 11 Section 12, the notifications, techniques applied including
file shall be in an official language of the EC existing regulatory approvals (i.e. FDA 510(k)
member state where the chosen Notified Body or PMA clearance)
is located and/or in another Community • Brief description of design process, design
language the Notified Body agrees to. control, verification, validation
• Once completed, the design dossier has to
be a controlled document. It does not need 3. Design Dossier/Technical File
to be under document control, but it still needs Summary Information
to be controlled in some manner. Therefore a (reference to supporting documents filed in Part B)
complete pagination of the design dossier is • Comprehensive description of the system and
to be indicated. each functional component of the device and
the related accessories
• Summary of the essential data and results as
detailed in Part B
TÜV SÜD Product Service GmbH

2. PART B: Annexes • Test protocols: purpose, objective, applicable
standards, sample size rationale, aging
1. Essential Requirements Checklist conditions, test description, parameters,
• Table format: essential requirements, equipment, calibration, acceptance criteria,
applicability of requirements, standards or statistics
methods utilized to show compliance, location • Test reports: deviations and amendments
of supporting documentation, rationale or including justification, reference to raw data,
comments statistical analysis, interpretation and
• List of standards applied by the manufacturer conclusion(s), signature(s)
• Justification is required should any of the
2. Risk Analysis (Annex I.1 to I.6) above not apply
• All hazards known or reasonably foreseeable
in both normal and fault condition, together 4.2 In Vivo Testing - Preclinical Studies
with the likelihood and consequences of • GLP animal studies
occurrence and measures taken to reduce • Objectives, methodology, rationale,
the resulting risks to acceptable levels transferability to humans, limitations
• Demonstration of appropriate risk analysis; • Pharmacological/pharmacokinetical/
conclusion that the remaining risks are toxicological studies
acceptable when weighed against the • Results, analyses of the functional
benefits; results to be reviewed and approved effectiveness and the device's interactions
• EN ISO 14971, EN 22442-1/2/3, MEDDEV 2.5-8 with animal fluids and tissues, statistical
analysis, conclusions
3. Drawings, Design- and Product –
Specifications 4.3 Biocompatibility Tests (Annex I.7)
• Most important technical data (to be • Purpose, scope
specified), reports, attachments, photographs, • List of components/materials having direct or
blueprints, flowcharts, product samples indirect body contact including their
characteristics, additives, total contacting
4. Chemical, Physical (mechanical safety surface area, description of tested item(s),
and performance) and Biological Tests sterile state, extract preparation, rationale
(Annex I.2, I.12) • Categorization of the device according to
the nature and duration of body contact
4.1 In Vitro Testing - Preclinical Studies • Tests performed (qualification of the test
• If applicable, visual, chemical, biological, laboratory; accreditation) according to
physical/mechanical testing (i.e. tensile ISO 10993-1 and GLP
strength, durability, corrosion, fatigue, long- • Action taken on positive results
term stability), efficacy/performance testing, • Justification for tests not performed, waiving
simulated use, FEA, compatibility to drugs or of tests to be recorded
chemicals, nanoparticle technology • Interpretation and conclusion of manufacturer
• Use of finished (sterilized) and aged (according
to shelf life claim) product

3. 4.4 Bio-stability Tests 4.8 Coated Medical Devices (Bio-mimicry)
Influence of the biological matrix on the device Stability of coating in biological matrix,
physiological/pathologic reactions,
4.5 Microbiological Safety, Animal Origin microbiological evaluation
tissue (Annex I.8.2)
For all medical devices utilizing material of 5. Clinical Data (Annex I.1, I.6)
animal origin, three separate Med-Infos are • Data from market experience of the same
available. These documents provide current or similar devices, clinical investigations
information on the requirements on the and information from scientific literature
documentation for this type of devices, issues of • MDD Annex X, ISO EN 14155-1+2,
viral safety and the validity of EDQM certificates MEDDEV 2.7.1
of suitability. Different types of medical devices For further information, separate Med-Infos on
utilizing material of animal origin are to be clinical data are available.
considered:
• devices consisting of material of animal origin 6. Labels and Instructions for Use - patient
(e.g. heart valves, hemostyptica) information - advertising material (Annex
• devices being coated with material of I.13)
animal origin (e.g. blood vessel replacements) • Requirements of the MDD (Annex I.13),
• devices that have been manufactured using EN 980, ISO 15223, EN1041
material of animal origin (e.g. fermentation • Description, indication for use,
products) contraindications, warnings, precautions,
adverse events, operation
4.6 Drug/medical device combination • Disposal information and safety information
products (Annex I.7.4) (Annex l.1 to l.6)
This type of product consists of a medical device
component and one or more of the following 7. Manufacturing
elements: • Multiple facilities, critical suppliers, contract
• a medicinal substance sterilizers, etc., copies of relevant certificates
• a blood product/blood derivative • Flow charts
• an advanced therapy medicinal product • Inspection and preventive monitoring steps
(gene therapeutics, somatic cells or tissue (bioburden, particles, pyrogens), deactivation,
engineering products); the requirements on the labeling control, traceability
documentation for this type of product are • Summary of manufacturing methods (molding,
detailed in separate Med-Infos extrusion, chemical process, assembly, etc.)
• Final product release criteria
4.7 Blood derivatives, human tissue/medical
device combination
See above.

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8. Packaging and shelf life (Annex I.4, I.5, 12. Compatibility to drugs (Annex l.7.3)
I.8.3, l.8.5, I.8.6, I.8.7) Devices must be compatible with the medicinal
• Detailed description of the packaging and products concerned according to the provisions
packaging materials, supplier certificates and restrictions governing these products.
• Physical package qualification, performance of
the product after real-time and/or accelerated 13. Other applicable directives and
aging, shelf life (expiration date), EN 868-1 ff, regulations
ISO 11607 • Registration, Evaluation, Authorisation and
Restriction of Chemicals REACH (Regulation
9. Sterilization (Annex I.8) (EC) No 1907/2006)
• Installation qualification and validation • Dangerous Preparations (1999/45/EC)
summary (SAL of 10-6) Brief description of applicablity and summary
• Process validation report with physical and of compliance with regulation.
microbiological performance qualification
• Sterilization plant certified by a Notified Body 14. Conclusion
(ISO 13485/8, EN 556, ISO 11135-1, Summary of the design dossier data including a
ISO 11137, ISO 17665-1) risk vs. benefit statement, signature of company
representative.
10. Measuring function (Annex I.10)
• Sufficient accuracy and stability within 15. Declaration of Conformity (draft only!)
appropriate limits of accuracy
• Council Directive 80/181/EEC
11. Combination with other medical devices
(Annex I.9.1)
The whole combination must be safe and must
not impair the specified performances of the
devices (e.g. electrical safety by combination
with active medical devices, Annex l.9.1).
Important note: This leaflet provides a rough overview only!
Prior to the compilation of design dossiers please contact for detailed scientific advice:
TÜV SÜD Product Services GmbH
August 2010/31 EU
Dr. Rainer Müller • Medical Health Services • Ridlerstr. 65 • 80339 Munich • Germany
E-mail: r.mueller@tuev-sued.de • Phone: + 49 89/50 08 41 39
Fax: + 49 89/50 08 42 87 • Alternatively visit us at: www.tuev-sued.com/mhs