Conformity Assessment and Risk Management under Consideration of Applicable Harmonized Standards. Dipl.-Ing. Sven Wittorf, M.Sc. Lübeck,

Transcription

1 Conformity Assessment and Risk Management under Consideration of Applicable Harmonized Standards Dipl.-Ing. Sven Wittorf, M.Sc. Lübeck,

2 Declaration of Conformity

3 Conformity Assessment Procedures Annex VII EC declaration of conformity Annex IV EC verification Annex III EC type-examination Annex V production quality assurance Annex VI product quality assurance Annex II full quality assurance system xxxx

4 Manufacture Design Conformity Assessment Procedures Annex VII EC declaration of conformity Annex IV EC verification Annex III EC type-examination Annex V production quality assurance Annex VI product quality assurance Annex II full quality assurance system xxxx

5 Conformity Assessment Procedures Annex VII EC declaration of conformity Annex IV EC verification not recommended Annex III EC type-examination Annex V production quality assurance Annex VI product quality not recommended assurance Annex II full quality assurance system xxxx According to NB-MED/2.2/Rec4

6 Conformity Assessment Procedures Annex VII EC declaration of conformity Annex IV EC verification Annex III EC type-examination Hardly applicable Annex V for software production quality assurance Annex VI product quality assurance Annex II full quality assurance system xxxx

7 Class I all the rest Conformity Assessment Procedures Annex VII EC declaration of conformity Annex IV EC verification Annex III EC type-examination Annex V production quality assurance Annex VI product quality assurance Annex II full quality assurance system xxxx

8 Annex IX Classification of Software Stand alone software is considered to be an active medical device. MDD Annex IX Definition 1.4

9 Annex IX Classification of Software Active devices intended for diagnosis are in Class IIa [ ] if they are intended to allow direct diagnosis or monitoring of vital physiological processes [ ] MDD Annex IX Rule 10

10 Annex IX Classification of Software Active devices [ ] specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient [ ], are in Class IIb MDD Annex IX Rule 10

11 Annex IX Classification of Software All other active devices are in Class I. MDD Annex IX Rule 12

12 yes yes Annex IX Classification of Software direct diagnosis or monitoring of vital physiological processes? no Other rules apply (e.g. rule 9)? yes Class according to other rule(s) variations of parameters could result in immediate danger? Class I Class IIa Class IIb

13 Guideline on Classification MEDDEV 2.1/6 Classification of Standalone Software

14 Essential Requirements The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned. MDD Article 3 Essential requirements

15 Essential Requirements The devices must be designed and manufactured in such a way that [ ] they will not compromise [ ] the safety of patients [ ] MDD Annex I Essential Requirement #1

16 What is Safety? Safety: freedom from unacceptable risk ISO/IEC Guide 51:1999, definition 3.1, cited in ISO 14971:2012

17 Essential Requirements Requirements Tests The devices must achieve the performances intended by the manufacturer [ ] MDD Annex I Essential Requirement #3

18 Essential Requirements For devices which [...] are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, [ ]. MDD Annex I Essential Requirement #12.1a

19 Essential Requirements Requirements For devices which [...] are medical software in themselves, the software must be validated according to the state of the art Architecture taking into account the principles of development lifecycle, risk management, Design [ ]. Integration Tests Module Tests Tests Implementation MDD Annex I Essential Requirement #12.1a

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21 Long long before Konrad Zuse

22 Risk Management 1 Identify risks 2 Estimate and assess risks 3 Control risks

23 Quality Management 1 Plan things 2 Do things 3 Check if things have been done according to the plan

24 Medical Software????????

25 Harmonized Standards Member States shall presume compliance with the essential requirements [...] in respect of devices which are in conformity with [...] harmonized standards [...] MDD Article 5 Reference to standards

26 Harmonized Standard

27 Harmonized (Process) Standards Medical Device Directive 93/42/EEC requires requires requires requires SW Lifecycle Processes Quality Management Risk Management Usability requires requires EN EN ISO EN ISO EN requires requires

28 Technical Documentation The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. MDD Annex VII EC Declaration of Conformity

29 Technical Documentation 39

30 Recommendation NB-MED/2.5.1/Rec5 Technical Documentation

31 Summary: Medical Software

32 Any questions? 43