Electronic medical equipment.

Medical Engineering medical facilities Medical Apparatus Medical instrument By type use energy electromedical apparatus Mechanical electromedical apparatus by direction energy flow Have action devices Perceptive devices

Perceptive devices By type energy, perceptive light energy chemical energy heat energy electrical energy Mechanical energy

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

Electromagnetic Energy Exchange is bidirectional

Technical Frequencies The technical frequencies table gives you an idea about the use and about the compatibility problems that arise from overlapping spectra. Overlapping spectra must be kept apart by appropriate measures. This is precisely the aim of EMC as a science and as a collection of rules.

electromedical apparatus sensor, converter, Output device Power sappy

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

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

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

Safety and Regulatory Affairs / Introduction - Risk Analysis According to EN 1441 - Failure Mode and Effect Analysis (FMEA) fault mode safety means S P D R ok? power outage (device stops) emergency power system 8 1 10 80 ok contact with hot wire (electrical shock) application of standard EN 60601-1 8 4 128 1 32 ok 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

Safety and Regulatory Affairs / Introduction - Summary - 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 Documentation is necessary to demonstate appropriate risk management

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

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:                   

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.

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

Medical Devices Directive - Articles and Annexes - 23 articles (definitions, reference to standards, ...) Annex I Essential Requirements Annexes II-VIII Assessment Procedures Annex IX Classification Criteria Annex X Clinical Evaluation Annex XI Notified Bodies Annex XII CE Marking

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, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.

Medical Devices Directive - Examples for Medical Devices - wheel chairs patient beds wound dressings respiration tubes products for transition of blood blood pressure monitoring endoscopes x-ray MRI artificial joints prosthetic heart valves artificial joint all accessories of medical devices (e.g. electrodes) 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. S19

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

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

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

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

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

Conformity Assessment - Introduction - If a product complies with the requirements of a new approach directive, the manufacturer signs a conformity declaration. Depending on the potential risk of the device certification by a Notified Body may be required. 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. Products which require certification by a Notified Body carry the CE-marking in combination with the number of the Notified Body, for example:

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

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

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

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

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

Conformity Assessment - Type Examination & Verification - 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 additional requirements - Quality Assurance - 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). ISO 9001/2 20/19 standard elements EN 46001/2 additional requirements S19

Conformity Assessment - Quality Assurance - Element Additional Requirements acc. to EN 46001 2. Quality system – set up a product file – include safety requirements in design input data – document design verification incl. clinical investications 4. Design control 8. Identification and traceability – establish procedures for traceability to facilitate corrective action – 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 S19

Conformity Assessment - Quality Assurance - General Requirements acc. to EN 9001 (excerpt) 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 S19

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

Conformity Assessment - Summary - 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. Manufacturer chooses procedure and procedure. CE-mark with / without number of Notified Body.

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

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

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

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