v UNECE WP6 panel session new Market Surveillance systems 3 November Geneva I. Hendrikx

2 Contents of this presentation 1.Introduction 2.Pre-market control versus post-market surveillance 3.Definition of Market Surveillance 4.Ranking of MS systems 5.Classification of products 6.Cost aspects of MS actions 7.Preliminary conclusions and way forward

3 1. Introduction Some basic thoughts.. Market surveillance refers to actions when product is on the market Are services included? (we assume not) Essential remarks New legislative trends vote for less pre-market involvement of authorities There are millions of products brought on the market each year Some kind of assessment of this large volume of products would mean a lot of costs/manpower

4 1. Introduction How does this translate to legal and practical implementations? We need a clear definition of what is Market Surveillance Efforts needed cover interactions between countries/regions: we need a vision and budget Existing legal field may be hampering an effective MS system

5 1. Introduction Some ideas to go forward.. Make a business plan for an effective MS system Develop a general procedure for different fields

6 1. Introduction Some more advanced ideas to go forward.. Transparency for all players requires advanced reporting methods Classification of essential requirements Simulation of stochastic data and introducing ‘what-if” scenarios would de-mystify the MS landscape Linking essential requirements, risk assessment, statistic methods and conformity assessment results

7 2. Pre-market control versus Post-market surveillance

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9 3. Definition of Market Surveillance According to latest definition of EC ‘market surveillance’ shall mean the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Community harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection (Regulation 765/2008)

10 4. Ranking of MS systems 1.Partial surveillance of harmonized legislation 2.Surveillance of all harmonized legislation 3.Surveillance of all harmonized legislation + non-regulated fields 4.Fully integrated database (classified items) 5.Participation to cross-border projects 6.Initializing and leading cross-border projects 7.Research in MS field

11 5. Classification of products s Category of product Description of relevant features Number of applicable legislation Example 1“simple” (technical) products 1 LVD Household ironer 2“medium complex” (technical) products 2 LVD, EMC Household toaster (incl. electronic timer) 3“complex” (technical) products 3 LVD, EMC, MD Machine tool 4Critical consumer product 3 or more LVD, EMC, Dang. Subst, R&TTE Toy Xnon-regulated4-5 harmonized + X non-regulated Intelligent textiles worn on people (expl. Hazard/EMF) Inherently safety critical features, user, complexity

12 6. Cost aspects of MS actions Country X, surveillance of 1 directive (LVD), product: household ironer, per year The market Number of electric irons on market15000 pieces Sample size (ISO )315pieces Assessment costs (AC) Administrative checks30 € x € Testing (2 Ers)400 € x € Total assessments22050€ Sample costs, transport, etc.315 x100 €31500€ Incomeestimated5513€ MSA costs (staff fees, overheadest. 20% of AC4410€ indirect costs) Overall cost for 1 MS action52448 €

13 6. Cost aspects of MS actions But there are much more household products on the market… say 10 times more →0.5 M€/per MS action but there are 24 other directives… (not to count the estimated 30% non-harmonized products) say 10 times more → 5 M€/per MS action The above figures are estimates

14 7. Preliminary conclusions and way forward No classification of ERs in technical legislation No classification of critical safety requirements in applicable (product) standards A Business Plan approach to MS actions reveals substancial costs Possible way forward We need more data and a system approach to get a believable MS system And adding valuable inputs of stakeholders