1. Workshop on conformity assessment procedures and certification of medical devices INT MARKT 43755 Kyiv, 28-29 November 2011 Conformity assessment of medical devices system in European countries. (Directive 93/42 EEC for medical devices). Requirements for technical documentation. Philippe Bauwin Medical devices expert retired coordinator of the medical device department of the Federal Agency for Medicinal and Health Products Belgium Mailto: philippe.bauwin@ yahoo.fr

2. The first part of my presentation will be a short reminder of the basic principles regarding the the new approach european directives. In the 2 nd part I will describe the objective and the requirements for the technical documentation as found in the 93/42 directive and explicited in various guidance documents In the 3d part I will talk about the interest of the technical documentation for the competent authorities, the notified bodies and the manufacturers

3. I recommend to read the Guide to the implementation of directives based on the new approach and the global approach called « Blue Guide » http://ec.europa.eu/enterprise/policies/single-market-goods/documents/blue-guide/index_en.htm It will explain you how the system works, what are the obligations of the manufacturers, what is the role of the competent authorities and the notified bodies and what is the technical documentation for and the main european directive on medical device 93/42 that is available on: http://ec.europa.eu/health/medical-devices/index_en.htm together with the other medical devices directives, useful links and many guidance documents

4. Other reference documents: Guidance documents published by various organisations provide specific advice about the technical documentation. For example: Recommendation NB-MED/2.5.1/Rec5 Technical Documentation by the Co-ordination of Notified Bodies Medical Devices (NB-MED) available on http://www.team-nb.org/index.php?option=com_docman&Itemid=38&lang=en And GHTF/SGlINOll:2008 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Published by the Study Group 1 of the Global Harmonization Task Force available on: http://www.ghtf.org

5. Concept of the new approach and the global approach Legislative harmonisation is limited to essential requirements that products must meet Technical specifications of products meeting the essential requirements are laid down in harmonised standards Application of harmonised or other standards remains voluntary, and the manufacturer may always apply other technical specifications to meet the requirements Products manufactures in compliance with harmonised standards benefit from a presumption of conformity with the corresponding essential requirement

6. Conformity Assessment Before placing a product on the market, the manufacturer must subject the product to a conformity assessment procedure provided in the applicable directive, with the view of affixing the CE marking. The procedure depends on the risk of the product.

7. Notified Bodies Third party conformity assessment is carried out by notified bodies, which have been designated by the Member States among bodies that fulfil the requirements laid down in the directive

8. CE marking Products in compliance with all provisions of the applicable directives providing for the CE marking must bear this marking. The CE marking is an indication that the products comply with the essential requirements and that the products have been subject to the requested conformity assessment procedure.

9. Role of the Member States In this system Member States don’t deliver pre-market approvals. They are not allowed to restrict the placing on the market and putting in service of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product Member States must protect the CE mark by exerting a market surveillance on their territory. They may request the technical documentation, a summary of it or a part of it for market surveillance purposes or during incident evaluations

10. Requirements for the technical documentation As described in the Blue Guide: New Approach directives oblige the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements As a rule, the documentation should cover the design, manufacture and operation of the product. The details included in the documentation depend on the nature of the product and on what is considered as necessary, from the technical point of view, for demonstrating the conformity of the product to the essential requirements of the relevant directive. The documentation should always be in a language understood by the notified body

11. Requirements for the technical documentation As described in MD 93/42 european directive The documentation must allow an understanding of the design, the manufacture and the performances of the product and must contain the following items in particular: — a general description of the product, including any variants planned, and its intended use(s), — design drawings, methods of manufacture, in particular as regards sterilisation, and diagrams of components, sub-assemblies, circuits, etc., — the descriptions and explanations necessary to understand the above- mentioned drawings and diagrams and the operation of the product, — a list of the standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements if the standards have not been applied in full, — the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out, — a statement indicating whether or not the device incorporates, as an integral part, a substance, or human blood derivative,, and the data on the tests conducted in this connection which are required to assess the safety, quality and usefulness of that substance, or human blood derivative, taking account of the intended purpose of the device, — a statement indicating whether or not the device is manufactured utilising tissues of animal origin

12. Requirements for the technical documentation As described in MD 93/42 european directive (following) — the solutions adopted for the design and construction of the devices to conform to safety principles, taking account of the generally acknowledged state of the art — the pre-clinical evaluation, — the clinical evaluation — the draft label and, where appropriate, instructions for use. -the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used

13. Requirements for the technical documentation NB Med and GHTF guidances The NB-MED/2.5.1/Rec5 guidance on technical documentation provides additional guidance It describes also a part A and B of the technical documentation. Part A is a summary technical documentation and is similar to the STED described in the GHTF/SGlINOll:2008 guidance Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) It is intended for example as a lead-in summary document that can be presented to evidence compliance to an authority a) during an incident investigation or b) as part of a post-market surveillance activity Authorities or notified bodies with knowledge of the format of the STED, can always, at the time of, during or as a follow-up to the request or assessment, ask that full rather than summary documentation be provided

14. CONTENTS OF THE SUMMARY TECHNICAL DOCUMENTATION STED Device Description and Product Specification, Including Variants and Accessories Device Description Product Specification Reference to similar and previous generations of the device Labelling Design and Manufacturing Information Device Design Manufacturing Processes Design and Manufacturing Sites Essential Principles (EP) Checklist Risk Analysis and Control Summary

15. CONTENTS OF THE STED (following) Product Verification and Validation General Biocompatibility Medicinal Substances Biological Safety Sterilisation Software Verification and Validation Animal Studies Clinical Evidence

16. The technical documentation and the manufacturer New Approach directives oblige the manufacturer to draw up technical documentation containing information to demonstrate the conformity of the product to the applicable requirements This obligation begins when the product is placed on the market, whatever its geographical origin is. The directives specify how much time this technical documentation must be kept. The technical documentation is not only an obligation but also a part of a good quality assurance system. By keeping a good technical documentation the manufacturer is sure to make a well defined product with a constant quality, with a good design and no deviation from the original verified design

17. The technical documentation and the competent authorities The technical documentation must be made available to the surveillance authority within a period of time commensurate with its importance and the risk in question, but the authority cannot request it systematically. In general, it can be requested only during random checks made for market surveillance purposes, or when there are grounds for a concern that a product does not offer the level of protection required in all respects (for example during the investigation of serious incidents ). Initially the surveillance authority may be provided with only a summary of the technical documentation (the essential technical data), if it has been drawn up, with reasonable time allowed for transmission. More detailed information (for example certificates and decisions from the notified body) can, nevertheless, be requested in cases of serious doubt about the conformity of the product to the Community regulations. The full technical documentation should be requested only where clearly necessary, and not, for example, when only a detail has to be checked

18. The technical documentation and the notified bodies Notified bodies will assess the technical documentation during conformity assessments, surveillance audits or inspections. According to the risk class of the product and the procedure choosen by the manufacturer for the conformity assessment this will be done on a product by product base or on a sampling base.

19. I thank you for your attention