1. Electronic medical equipment.

2. Medical Engineering medical facilitiesMedical ApparatusMedical instrument By type use energy electromedical apparatus Mechanical electromedical apparatus by direction energy flow Have action devices Perceptive devices

3. By type energy, perceptive chemical energylight energy heat energy electrical energy Mechanical energy

4. Have action devices Have action devices therapeuticdiagnostical electrical energy mechanical energy mechanical hydraulic light - optical gas ultra sound low frequency X-ray by function By type influence high frequency

5. Electromagnetic Energy Exchange is bidirectional

6. Technical Frequencies

7. electromedical apparatus sensor,sensor, converter,converter, Output deviceOutput device Power sappyPower sappy

9. Heinz-Eckhard Schmittendorf Safety and Regulatory Affairs Siemens AXIOM Artis BA 1. Introduction 2. The Medical Devices Directive 3. Conformity Assessment Procedure 4. Exercise and Discussion

10. What is the intended use of the device? What potential risks do you see? Assess these risks. Are they acceptable? Safety and Regulatory Affairs / Introduction What can the manufacturer do to reduce these risks? How can the manufacturer prove that safety of the device is sufficient?

11. Safety and Regulatory Affairs / Introduction - Risk Analysis According to EN 1441 - identify characteristics & intended use identify possible hazards estimate risk for each hazard risk acceptable? reduce risk remaining risk acceptable? re-design yes risk analysis report / review

12. Safety and Regulatory Affairs / Introduction - Risk Analysis According to EN 1441 - Failure Mode and Effect Analysis (FMEA) fault modesafety meansSPDRSPDRok? power outage (device stops) emergency power system 8110801110 ok contact with hot wire (electrical shock) application of standard EN 60601-1 84 412881432ok S - severity of consequences (1..10) P - probability of occurrence (1..10) D - detectability (1..10) R - risk = S x P x D (1..1000), threshold of acceptability = 50

13. The use of medical devices involves specific risks It is the manufacturer's responsability to - identify potential risks, - evaluate the acceptability - reduce risks to an acceptable level The application of standards helps to ensure a high level of safety Safety and Regulatory Affairs / Introduction - Summary - Documentation is necessary to demonstate appropriate risk management

14. Safety and Regulatory Affairs Siemens AXIOM Artis BA 2. The Medical Devices Directive

15. Medical Devices Directive - The „New Approach“ - In 1985 the European Union agreed on a "new approach" to the regulation of technical aspects of industrial products. Where harmonization of legal requirements or administrative regulations is necessary, the European Union develops regulations, which are called Council Directives or simply directives. Directives specify only the essential requirements that are general and mandatory. The detailed technical specifications that may be used to demonstrate conformity with the essential requirements are elaborated in voluntary harmonized standards. If a product complies with the requirements of a new approach directive, the manufacturer marks it with the CE-mark:

16. Medical Devices Directive - The „New Approach“ - CE-marked goods are allowed free movement within the internal market throughout the territory of the European Economic Area (EEA). EEA = EU member states plus Norway, Iceland and Liechtenstein Approach has been adopted by other states (e.g. Hungary, Czechia) and is recognized in many other countries.

17. Medical Devices Directive - MDD, standards, and national legislation - Organizations for Standardization Harmonized Standards Medical Devices Directive 93/42/EWG (MDD) EU Medical Devices Act (MPG) National Governments

18. Medical Devices Directive - Articles and Annexes - 23 articles (definitions, reference to standards,...) Annex IEssential Requirements Annexes II-VIIIAssessment Procedures Annex IXClassification Criteria Annex XClinical Evaluation Annex XINotified Bodies Annex XII CE Marking

19. Medical Devices Directive - Definition of a Medical Device - Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manu- facturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of diseases, injuries, or handicaps, diagnosis, prevention, monitoring, treatment or alleviation of diseases, injuries, or handicaps, investigation, replacement or modification of the anatomy or of a physiological process, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.

20. wheel chairs wheel chairs patient beds patient beds wound dressings wound dressings respiration tubes respiration tubes products for transition of blood products for transition of blood blood pressure monitoring blood pressure monitoring endoscopes endoscopes x-ray x-ray MRI MRI artificial joints artificial joints prosthetic heart valves prosthetic heart valves artificial joint artificial joint all accessories of medical devices (e.g. electrodes) all accessories of medical devices (e.g. electrodes) S19 Medical Devices Directive - Examples for Medical Devices - Note: A medical device must have a proven efficacy for specific medical purposes. Neither „Miracle Products“ nor general wellness products, cosmetic products, fitness apparatus etc. (e.g. muscle training apparatus, tooth whitener etc.) are recognized as medical devices.

21. Medical Devices Directive - Essential Requirements - General Requirements: - state of the art safety of patients, operators and third persons - device must achieve intended performances Chemical, physical and biological properties Infektion and microbial contamination (incl. sterility) Construction and environmental properties Measuring function Protection against radiation (incl. EMC) Safetey of external or internal energy supply (electrical safety, software, alarm systems, etc.) Information, labelling, instructions for use

22. Annex I: Essential Requirements electrical safety biological safety sterilisation …. EN 60601 Electrical Safety Presumption of conformity for the aspects that are covered by the standard. Application of harmonized standards is optional. EN 30993 Biological Evaluation EN 550 ff. Sterilisation Medical Devices Directive - Compliance with Essential Requirements -

23. S13 Medical Devices Directive - Compliance with Essential Requirements - application of EN 60601-1 „Medical electrical equipment. Part 1: General requirements for safety“ requirementapplicable?ensured by 12.6Protection against electrial risks... avoid the risk of accidental electris shocks during normal use and in single fault condition... yes

24. This Product complies with the Essential Requirements of the Directive 93/42/EEC. The Manufacturer Medical Devices Directive - Declaration of Conformity -

25. Product Description intended use / application scope / contra indications variations and approved accessories instructions for use / operation manual advertising materials / brochures / leaflets Product Specification construction drawings, manufacturing plans, part lists essential requirements / list of applied standards manufacturing and sterilisation specifications QS specifications (SOP, testing plans) labelling and user information (EN 1041) Product Verification risk analysis (EN 1441) test and inspection records, certificates clinical data / clinical assessment Conformity Declaration Medical Devices Directive - Technical Documentation -

26. “New approach”: Essential Requirements and harmonized standards Medical Devices Directive - Summary - Technical Documentation Definition “medical device” MDD

27. Safety and Regulatory Affairs Siemens AXIOM Artis BA 3. Conformity Assessment

28. - Introduction - l If a product complies with the requirements of a new approach directive, the manufacturer signs a conformity declaration. l Depending on the potential risk of the device certification by a Notified Body may be required. l If certification is a requirement as part of the conformity assessment procedure, the manufacturer has the option to choose any of the Notified Bodies in any of the Member States of the EU. l Products which require certification by a Notified Body carry the CE-marking in combination with the number of the Notified Body, for example:

29. 18 classification rules (Annex IX) low Risk high I III IIb IIa I * sterile or with a measuring function S17 Conformity Assessment - Risk Classes -

30. invasive / non-invasive invasive / non-invasive surgically invasive / non-surgically invasive surgically invasive / non-surgically invasive implantable / non-implantable implantable / non-implantable active / non-active active / non-active short-term / long-term use short-term / long-term use application on „critical“ organs (central nervous system, central blood circulation system) application on „critical“ organs (central nervous system, central blood circulation system) Conformity Assessment - Criteria for Risk Classification - intended use

31. Class I wheel chairs, patient beds, non-invasive electrodes Class I wheel chairs, patient beds, non-invasive electrodes Class I* sterile wound dressings, thermometer Class I* sterile wound dressings, thermometer Class IIa ultrasound diagnostic device, respiration tubes, blood pressure monitoring devices, products for transition of blood Class IIa ultrasound diagnostic device, respiration tubes, blood pressure monitoring devices, products for transition of blood Class IIb artificial joints, lithotripthers Class IIb artificial joints, lithotripthers Class III prosthetic heart valves, neurologic catheters Class III prosthetic heart valves, neurologic catheters S19 Conformity Assessment - Examples for Risk Classification -

32. I III IIb IIa manufacturer Ann. II with design examination Annex VII + Annex IV, V or VI Annex II without design examination or Ann. III + Ann. IV, V or VI Annex VII sterile or with a measuring function: Annex V notified body Ann. III + Ann. IV or V ) I * S20 Conformity Assessment - Procedures -

33. Technical Documentation Annex VII EC- Declaration of Conformity Annex III EC - Type Examination Annex II Full Quality Assurance - 9001/46001 Annex II Full Quality Assurance + Design Examination - 9001/46001 - Examination of Techn.Docu Annex IV EC-Verification - each device - samples Annex V QA Production - 9002/46002 Annex VI QA Product - 9003/46003 CECE + Number of Notified Body I I* IIaIIb IIIIIa IIbIII I* IIa IIb IIII* IIa IIb I Conformity Assessment - Procedures -

34. EC-Type Examination Notified Body examins technical documentation and performs tests on a prototype to ensure conformity with essential requirements EC - Verification Notified Body performs tests on every device or samples from current production to ensure conformity with technical documentation and essential requirements S19 Conformity Assessment - Type Examination & Verification -

35. Notified Body performs audit of the manufacturers quality assurance system. QA-system has to apply to EN 9001 (general QA) and EN 46001 (additional requirements to medical devices). S19 Conformity Assessment - Quality Assurance - ISO 9001/2 EN 46001/2 additional requirements 20/19 standard elements

36. S19 Conformity Assessment - Quality Assurance - – establish procedures for traceability to facilitate corrective action 8. Identification and traceability – include safety requirements in design input data – document design verification incl. clinical investications 4. Design control – set up a product file2. Quality system Additional Requirements acc. to EN 46001Element – documented feedback system for early warning and corrective actions – document and investigate all feedback incl. complaints – maintain procedures for recall actions 14. Corrective and preventive action – retain quality records for a time period at least equivalent to the life-time of a product, but not less than 2 years 16. Quality records

37. S19 Conformity Assessment - Quality Assurance - 1. Management responsability 2. Quality system 3. Contract Review 4. Design control 6. Purchasing 7. Control of custumer-supplied product 8. Identification and traceability 9. Process Control 10. Inspection and testing 11. Control of inspection, measurement and test equipment 14. Corrective and preventive action 18. Training 20. Statistical techniques General Requirements acc. to EN 9001 (excerpt)

38. define intended use of the device define intended use of the device set up and maintain the technical documentation incl. risk analysis set up and maintain the technical documentation incl. risk analysis classify the device classify the device choose a conformity assessment procedure choose a conformity assessment procedure perform conformity assessment (if required with Notified Body) perform conformity assessment (if required with Notified Body) issue the declaration of conformity and affix the CE marking issue the declaration of conformity and affix the CE marking Conformity Assessment - Steps to CE-Marking -

39. Possible conformity assessment procedure depends on risk classification. Procedures with / without involvement of Notified Body. Procedures based on product testing or audit of quality assurance system. Conformity Assessment - Summary - CE-mark with / without number of Notified Body. Manufacturer chooses procedure and procedure.

40. Safety and Regulatory Affairs Siemens AXIOM Artis BA 4. exercise & discussion

41. Safety and Regulatory Affairs - Exercise - Choose a medical device, then carry out Risk Analysis Basic Requirements & Standards Classification and choice of an appropriate Conformity Assessment Procedure

42. Is a medical device that bears the CE-mark save? Why? Do you see any weak spots in the current regulatory system? Safety and Regulatory Affairs - Discussion - Any other questions?

43. Heinz-Eckhard Schmittendorf Safety and Regulatory Affairs Siemens AXIOM Artis BA 1. Introduction 2. The Medical Devices Directive 3. Conformity Assessment Procedure 4. Exercise and Discussion