Mapping Your Success Staying Current on Standards Under the EU Approach

Transcription

1 Mapping Your Success Staying Current on Standards Under the EU Approach

2 Overview What is a Standard? Why use Standards? EU Harmonized Standards what does it mean? EU Standards Harmonization Process Annex Z s the Informatives Staying Current with Standards EU Guidance Documents 2

3 Overview Common Technical Specifications (CTS) ISO The Future Conclusions 3

4 What is a Standard? A standard is an agreed way of doing something. It could be about making a product, managing a process, delivering a service or supplying materials It is a document derived by consortia and approved by a recognized body 4

5 Consensus ISO/IEC Guide 2:2004, definition 1.7 General agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments. NOTE Consensus need not imply unanimity. 5

6 Standards Development Process Proposal Review Drafting Publication Public Inquiry Final Approval Comment Resolution 6

7 Standards Published 7

8 Categories of Standards Specification Highly prescriptive standard setting out detailed absolute requirements Codes of practice Recommend sound good practice as currently undertaken by competent and conscientious practitioners Method Highly prescriptive, setting out an agreed way of measuring and testing a parameter in reliably repeatable manner 8

9 Categories of Standards Vocabulary Agreed set of terms and definitions to help harmonize the use of language in a particular subject or discipline Guides Less prescriptive advice which reflects the current thinking and practice amongst experts in a particular subject 9

10 Why Use Standards? Compliance Standards are voluntary and not usually required by regulation Standards can be developed to support particular policy aims, including regulation Standards offer a means of compliance with new approach European Directives 10

11 Why Use Standards? Client All stakeholders want safety & performance Easy definitions via agreed standards Certification Global medical device regulation Standards enable innovation 11

12 British Standards Institution The Beginnings BSI began in 1901 with the first meeting of the engineering Standards Committee, convened by John Wolfe-Barry, designer of London s Tower Bridge 12

13 Regulations vs Standards Regulations Geographic Area e.g. The EU / National Mandatory Political influence Often objectives-based Difficult to change Standards International (preferably) Voluntary Voting, consensus based Mostly technical requirements Periodic update (state of the art) 13

14 European Standards How to harmonize a standard? Adhere to Commission mandate Initiate New Work Proposal Involve all stakeholders Develop standard in consensus mode taking due account of the essential requirements Develop Annex Z: which ER s covered? Comment and weighted voting process in EU Approve by CEN/CENELEC consultant Publish in the Official Journal of the EU 14

15 European Standards Comment and weighted voting process in EU Approve by CEN/CENELEC consultant Publish in the Official Journal of the EU 15

16 Article 5 - Standards Member States shall presume compliance with the essential requirements referred to in Article 3 in respect of devices which are in conformity with the relevant harmonized standards. Harmonized standards have Annex Z 16

17 Use of Standards First choice is harmonized standards Then European (ENs not harmonized) International (ISO/IEC) EU national (BS/DIN/FN) Other national (CSA/ANSI/ASTM) Manufacturer s specifications 17

18 Which Year? Most up-to-date list of Harmonized Standards ESO(1) Reference and title of the harmonised standard (and reference document) CEN EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version ) First publication OJ Reference of superseded standard 30/08/2012 EN ISO 14971:2009 Note 2.1 Date of cessation of presumption of conformity of superseded standard Date expired (30/08/2012) CEN EN 1041:2008 EN Information supplied by the 1041:1998 Date expired 19/02/2009 manufacturer of medical (31/08/2011) devices The most up to date list of Harmonized Note standards

19 EU Standards Use Tip #1 Is the Use of Harmonized standards mandatory? NO, however they are legally defined as state of the art Where devices do not comply with key relevant published standards, a rationale should be given. NBMed

20 EU Standards Use Tip #2 Are Harmonized standards the tools used by the Notified Body to assess conformity to the Directives? YES MedDev (2001) Responsibilities of the Notified Body under 93/42/EEC 20

21 MedDev Quality System To assess the procedures for controlling, monitoring and verifying the design of the device and its compliance with the requirements of the Directive To assess the capability of the manufacturer to use and interpret in the design process the essential requirements and the relevant standards for all product technologies used by the manufacturer 21

22 MedDev Design Examination Confirm that the product conforms to the relevant provisions of the Directive by verifying: that relevant standards have been applied or that the solutions adopted in the absence of standards, meet the essential requirements. 22

23 EU Standards Use Tip #3 Can you tell if a standard is Harmonized as it will have an EN prefix? NO Harmonized standards will be published in the Official Journal of the European Communities If you do not want to read every issue of the journal you can look for Annex ZA, ZB or ZC 23

24 ZA Annex ZA, ZB and/or ZC: EN ISO EN ISO EN ISO EN 980 EN 1041 EN ISO EN EN ISO EN ISO

25 EN ISO 14630:2009 Table ZA Correspondence between this European Clause(s) of this European Standard Standard and Directive 93/42/EEC Essential requirements from Annex I of 93/42/EEC a Qualifying Remarks Part of ER 1 relating to risk of use error is not addressed by this standard. Part of ER 7.1 relating to the results of biophysical modelling research is not explicitly addressed by this standard. 25

26 EU Standards Use Tip #4 If a manufacturer references a standard must they include the year? NO If there is no year present, the Notified Body will audit using the most recent. 26

27 EU Standards Use Tip #5 Can the Notified Body ask for more than is required by Harmonized standards? YES If the audit objectives include the Directive, then ask for evidence of compliance to the Directive. 27

28 EU Standards Use Tip #6 Must the manufacturer need to reference standards in the ER Checklist, in test reports and in procedures to ensure compliance to the Directives? NO, however the manufacturer must have a solution to show standards with which they are in compliance. 28

29 93/42/EEC Annex VII The technical documentation must allow assessment of the conformity of the product with the requirements of the Directive. It must include in particular: a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive if the standards have not been applied in full 29

30 EU Standards Use Tip #7 Does the manufacturer only need to check for key standards at the time the product is placed on the market? NO Design and development inputs (ISO 13485) Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include applicable statutory and regulatory requirements 30

31 EU Standards Use Tip #8 Is the manufacturer responsible to know which standards are applicable to their devices? YES Notified Bodies also need to be aware Perinorm TechStreet TechStreet finds fewer references for particular keywords 31

32 Perinorm Perinorm is a bibliographic database of national, European and international standards from over 200 organizations in 23 countries, a total of more than 1,400,000 records Perinorm is an online tool that sources its information directly from the Standards' producers and is updated monthly Perinorm is available in three languages (English, French & German) Perinorm is available on annual subscription 32

33 EU Standards Use Tip #9 Can Manufacturers get access via subscription to all Harmonized standards through BSOL? YES Access via subscription to over 50,000 British, European and international standards. 33

34 BSOL 34

35 EU Standards Use Tip #10 The manufacturer has not referenced any standards or procedures relating to specifics to demonstrate compliance with this requirement. Is this a non-conformity? YES 35

36 Guidance Documents MEDDEV Official guidance documents produced by the EU Commission Promote a common approach by manufacturers and Notified Bodies involved in the conformity assessment procedures according to the relevant annexes of the Directives, and by the Competent Authorities charged with safeguarding Public Health The guidelines are not legally binding devices/documents/guidelines/ 36

37 Guidance Documents NB-MED s Recommendations on the Directives from the European Notified Bodies Medical Devices Group. e.g. NB-MED/2.5.2/Rec 2, Titled Reporting of Design Changes and Changes of the Quality System. 37

38 Guidance Documents CONSENSUS STATEMENTS Agreed interpretations from the European Notified Bodies Medical Devices Group MedDev, NBMed, GHTF/IMDRF guidance documents are considered state of the art 38

39 Common Technical Specifications (CTS) CTS are effectively mandatory standards or standard which describe the current state of the art for Annex II list A and potentially for Annex II list B devices Commission Decision therefore effective immediately but may define transitional arrangements 39

40 Common Technical Specifications (CTS) They have scope to describe the requirements for product evaluation, reevaluation and batch verification but practically only contains performance evaluation criteria 40

41 Standards vs CTS Standards Support compliance the Essential Requirements Long process (3-4 years) Standardized language and format Voluntary CTS Support compliance the Essential Requirements Prepared relatively quickly The format and language is not standard De facto mandatory for Annex II List A 41

42 Common Technical Specification Referenced in Article 5 Prepared for Annex II List A devices Contain performance evaluation criteria CTS are prepared by an Expert Group of the Commission Manufacturers expected to comply with the CTS. lex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2009:318:0025:0040:en:pdf 42

43 Common Technical Specification COMMISSION DECISION of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance) (2009/886/EC) 43

44 CTS Sample Page 44

45 ISO ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes ISO is a sector-specific quality management system standard for medical devices which harmonizes regulatory requirements globally and is recognized as a suitable model for regulatory requirements for quality systems for medical devices by regulatory authorities 45

46 ISO Reasons for Revision ISO TC 210..contact with regulatory authorities, who have expressed their desire for ISO 13485:2003 to be revised in the light of developments in regulatory requirements and expectations Formal objection to the harmonization of the European adoption of ISO 13485:2005 led to extensive revision of the European forward and annexes to EN ISO 13485;.these revisions have been published in

47 ISO 13485: Selected Revision Areas Revision Area Scope Software validation Supply chain Outsourcing Nature of the Revision Scope statement to reinforce its focus on QMS requirements, not product requirements, and to emphasize that the QMS requirements in the standard apply throughout the life cycle of the products being designed, developed, manufactured, distributed and supported by the QMS. Expansion, as appropriate, of software validation requirements. Included would be process and QMS software and the design validation of software that is the medical device and software that is embedded in a medical device. Clarification of the different roles and relationships between the organization and other parties in the supply chain as defined in various regulatory regimes. Inclusion of additional requirements related to outsourcing. Possibly include them among requirements related to purchasing and control of suppliers. 47

48 ISO 13485: Selected Revision Areas Revision Area Risk management Post-market information gathering Adverse reporting Complaint handling Annex Zs to the EN ISO 13485:2012 Nature of the Revision Inclusion of requirements for risk management beyond the processes related to product realization and to processes related to the life cycle of the product. Include review of ISO 14971:2007 Inclusion of requirements related to post-market information gathering regarding product performance, and information gathering during the clinical evaluation of the product for purposes of design validation. The inclusion of requirements related to processes for ensuring the reporting of adverse events during clinical investigations. Expansion of specific requirements related to complaint handling that reflect the current regulatory requirements. Review of the Annex Z of EN13485 to identify any gaps that should be considered for revision. 48

49 ISO Anticipated Time Lines CD issued for public comment in May 2013 Voting period ended in August 2013 DIS to be drafted by October 2013 and issued in November

50 ISO Anticipated Time Lines Voting period will end in April 2014 FDIS anticipated to be published by July 2014 ISO 13485:201x to be published Q

51 Conclusions Standards (Harmonized) and Guidance documents are considered State of the Art..presumption of compliance with the essential requirements... in respect of devices which are in conformity with the relevant harmonized standards.. 51

52 Conclusion Trade is international Safety requirements are universal All stakeholders want safety & performance Facilitates cross border trade: 200+ countries Many manufacturers operate globally 52

53 Questions? 53