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D r . PAVEL KLENOVSKY , CMI General Director

What is the future of conformity assessment in Europe?. D r . PAVEL KLENOVSKY , CMI General Director. About conformity assessment activities (CAAs) associated with technical requirements for products represents personal views of the author, not an official position of the Czech Republic

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D r . PAVEL KLENOVSKY , CMI General Director

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  1. What is the future of conformity assessment in Europe? Dr. PAVEL KLENOVSKY, CMI General Director

  2. About conformity assessment activities (CAAs) associated with technical requirements for products represents personal views of the author, not an official position of the Czech Republic essentially about the situation in metrology (NAWI, MID – 2 directives out of 25) with some generalizations CONTENTS OF THE PRESENTATION

  3. The basic aim of those CAAs: to build up a true single market for products (inclusive measuring instruments) THE LONG-TERM DEVELOPMENT

  4. 1. stage – old approach directives (before 1980) too technically detailed directives, not able to keep pace with technological development were not able to eliminate national „specialities“ (barriers to trade) THE LONG-TERM DEVELOPMENT

  5. 2. stage – new and global approach (after 1980) pushed forward especially by manufacturers  liberalization towards them metrology labs playing the role of third party conformity assessment providers (notified bodies – NBs, only for NAWI 300 NBs out of the total of 1700) THE LONG-TERM DEVELOPMENT

  6. 3. stage – review of the new approach (at present) Basic findings: module A to be a liability in the system (up to 50 % failure rate during surveillance) varying standard of performance in modules with NBs different approaches to demonstration of technical competence in the Member States ineffective market surveillance (less than 5 % of products inspected) THE LONG-TERM DEVELOPMENT

  7. 3. stage – review of the new approach (at present) Basic findings continued: politically important Medical Devices Directive being a mess: essential requirements not tangible (no mpe´s for MDDs with a measurement function), up to 60 % of products non-compliant with the harmonized standards surprisingly, no analysis has been made to what extent accreditation is effective in guaranteeing technical competence of NBs THE LONG-TERM DEVELOPMENT

  8. multiple testing (in each country) exclusively by third party bodies third party testing, only once on the Single Market with some self-declaration options for manufacturers (module A – but exceptionally applied in metrology) assessment of the technical documentation (module H1) THE DEVELOPMENT of CAAs in the short cut

  9. the involvement of third parties (NBs) is being constantly reduced (the selection of modules is solely up to manufacturers) protection of public interest is endangered by this development a transition from independent testing to mere assessment of technical documentation is highly controversial (no equivalence) COMMENTS

  10. the next stage to be expected: zero involvement of NBs in the whole process (despite bad experience with module A) this fast pace of liberalization under the auspices of EC DG Enterprise not always in line with manufacturers´ wishes (manufacturers of building materials) COMMENTS

  11. problem of „gold-plated instruments“ being presented by manufacturers to independent testing – no true representation of day-to-day manufacture CONFORMITY TO THE APPROVED TYPE

  12. the Australian exercise in 2001: with the rise of mutual recognition agreements reducing the amount of testing the risks of non-complying instruments are higher post approval testing exercise: 25% rate of non-compliance CONFORMITY TO THE APPROVED TYPE

  13. nearly 100% of CA made by manufacturers based on their approved quality system (self-declaration) a number of examples of non-compliance with the approved type (Australia, Germany) but not publicly available CONFORMITY TO THE APPROVED TYPE

  14. it is an evidence how effective are modules based on an approved QS might be an indication what the situation might be in compliance to essential requirements under modules H, H1 all these problems should have been identified by market surveillance CONFORMITY TO THE APPROVED TYPE

  15. The entire concept is wrong: putting products on the single pan-European market should be supervised by way of national bodies those bodies are not knowledgeable in the underlying fields (in metrology especially sensitive) MARKET SURVEILLANCE (MS)

  16. very strange application of the subsidiarity principle the actions of MS are scarce (if at all existing), there is no coordination and exchange of information among national bodies  MS currently totally ineffective MARKET SURVEILLANCE (MS)

  17. Accreditors: ++ accreditation mandatory to demonstrate technical competence of NBs guaranteed monopoly position, even in the non-regulated area! a drop (or the same level) of activities in the regulated area but a strengthened position in the non-regulated area (80% of their turnover) REVISION OF THE NEW APPROACH – WHO WILL BENEFIT, WHO WILL LOSE

  18. Manufacturers: + in the short term, - for high-end ones a continuation of the process leading to a zero involvement of NBs standards of behaviour will go down with rising self-declarations  non-level playing field (high-end manufacturers will suffer) REVISION OF THE NEW APPROACH – WHO WILL BENEFIT, WHO WILL LOSE

  19. Notifying authorities: - for the ambitious one they should supervise NABs (instead of a multitude of national NBs) accreditation is able to take nearly all their responsibilities off their shoulders REVISION OF THE NEW APPROACH – WHO WILL BENEFIT, WHO WILL LOSE

  20. NBs: -- NBs (i.e. testing and metrology labs) will lose nearly in all the aspects they take on higher costs (accreditation) they will be losing business (self-declarations) REVISION OF THE NEW APPROACH – WHO WILL BENEFIT, WHO WILL LOSE

  21. MS bodies: + ? their role should be strengthened but with a doubtful result when the EC will not step in robustly REVISION OF THE NEW APPROACH – WHO WILL BENEFIT, WHO WILL LOSE

  22. CONCLUSIONS: protection of public interest will be further dented (it is not clear how the revision can achieve anything tangible here) laboratories as an important part of the service sector in Europe will lose a lot here WHO DESERVE SUPPORT IN THE CURRENT SITUATION

  23. MORE GENERAL QUESTIONS: should manufacturers be exceedingly supported by the EC after a lot of manufacture has been outsourced outside Europe? WHO DESERVE SUPPORT IN THE CURRENT SITUATION

  24. MORE GENERAL QUESTIONS: should labs (SMEs in the service sector) not deserve more support by the EC under the current circumstances? WHO DESERVE SUPPORT IN THE CURRENT SITUATION

  25. MORE GENERAL QUESTIONS: are there not barriers to trade to the operation of labs on the Single market (accreditation expensive but not able to take out cheaters among labs)? WHO DESERVE SUPPORT IN THE CURRENT SITUATION

  26. THANK YOU FOR YOUR ATTENTION! www.cmi.cz info@cmi.cz

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