Transcript UNECE WP6 panel session new Market Surveillance systems 3 November 2008 - Geneva I.

UNECE WP6 panel session
new Market Surveillance systems
3 November 2008 - Geneva
I. Hendrikx
v1 2008-10-28
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
2
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
3
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
4
1. Introduction

Some ideas to go forward..

Make a business plan for an effective MS system

Develop a general procedure for different fields
5
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
6
2. Pre-market control versus Post-market
surveillance
PAST
7
2. Pre-market control versus Post-market
surveillance
Harmonized area
Non-Harmonized
area
New Approach
Old
Approach
Number of
directives/regulations
25
500
Existing or
non-existing
national technical
regulations
% of EU intra-trade
60
10
30
8
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)
9
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
10
5. Classification of products
Inherently safety critical features, user, complexity
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
4
Critical consumer
product
3 or more
LVD, EMC, Dang. Subst,
R&TTE
Toy
X
non-regulated
4-5 harmonized
+
X non-regulated
Intelligent textiles
worn on people
(expl. Hazard/EMF)
s
11
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 market
Sample size (ISO 2859-1)
Assessment costs (AC)
Administrative checks
30 € x 315
Testing (2 Ers)
400 € x 31.5
Total assessments
Sample costs, transport, etc.
315 x100 €
Income
estimated
MSA costs (staff fees, overhead
est. 20% of AC
indirect costs)
Overall cost for 1 MS action
15000
315
pieces
pieces
9450
12600
22050
31500
5513
4410
€
€
€
€
€
€
52448 €
12
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
13
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
14