Med-Info Regular Information Bulletins for the Medical Device Industry Product ServiceDesign DossiersDesign dossiers are technical files for class III It is recommended to compile a Designdevices and comprehensively examined by the Dossier or Technical File as followsNotified Body. (see also NB-MED/2.5.1 and GHTF document SG1 (PD)/N011R20: STED):Medical Device Directive (MDD) Annex IISection 4.2 states that an application for PART A: Technical Fileexamination of the design of the product mustinclude the documents needed to assess 1. Table of Contentwhether the product conforms to therequirements of the MDD. 2. IntroductionDesign dossiers have to be submitted to the • Revision history of Design DossierNotified Body for review prior to CE marking of • Regulatory information, e.g. classificationthe product. We will assign a project manager of the device including the product codewho will entrust one or more further experts with according to the Universal Medical Devicethe review of particular modules. All experts are Nomenclature System and/or Global Medicalat 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 equipmentDirective 93/42/EEC certifying compliance with intended to be used in combination with thethe relevant provisions of Annex I of the MDD. device, applied standards, etc. • History of the device: market release, itemsProduct 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 BTÜV SÜD Product Service GmbH
PART B: Annexes • Test protocols: purpose, objective, applicable standards, sample size rationale, aging1. 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 the2. 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 devices interactions• EN ISO 14971, EN 22442-1/2/3, MEDDEV 2.5-8 with animal fluids and tissues, statistical analysis, conclusions3. 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 contacting4. 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 contact4.1 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
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 evaluationtissue (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 sameavailable. These documents provide current or similar devices, clinical investigationsinformation on the requirements on the and information from scientific literaturedocumentation for this type of devices, issues of • MDD Annex X, ISO EN 14155-1+2,viral safety and the validity of EDQM certificates MEDDEV 2.7.1of suitability. Different types of medical devices For further information, separate Med-Infos onutilizing 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, operation4.6 Drug/medical device combination • Disposal information and safety informationproducts (Annex I.7.4) (Annex l.1 to l.6)This type of product consists of a medical devicecomponent and one or more of the following 7. Manufacturingelements: • 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 criteria4.7 Blood derivatives, human tissue/medicaldevice combinationSee above.
Product Service www.tuev-sued.com/mhs 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: email@example.com • Phone: + 49 89/50 08 41 39 Fax: + 49 89/50 08 42 87 • Alternatively visit us at: www.tuev-sued.com/mhs