Industry

Market Surveillance

Government Decision no. 487/2016 on electromagnetic compatibility, transposing in the national legislation the Directive 2014/30/EU (EMC Directive) of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (recast), represents the legal framework for ANCOM as regards the market surveillance activity.
 
The EMC Directive continuously upholds a huge single European market of free-circulating electric and electronic products that fulfil its requirements. Market surveillance is vital for ensuring the integrity of this market.
 
As mentioned above, market surveillance falls within the measures covered by the "subsidiary" arrangements - in other words, it is a national matter.
 
The European Commission Blue guide gives, among other things, a general overview of market surveillance principles and of the responsibilities of EU Member States.
 
Also, on the 1st of January 2010 entered into force the Regulation (EC) no.765/2008 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products which contains requirements for market surveillance organisation, operation and collaboration.
 
Market surveillance involves two main stages:
- the national surveillance authorities must monitor whether products placed and/or made available on the market comply with the provisions of the applicable national legislation which transposes the provisions of the New Approach directives, and
- subsequently, if necessary, take action for non-compliant products to be made compliant.
 
National market surveillance authorities act towards determining the economic operators (manufactureres, their authorised representatives, importers, distributors) to voluntarily correct non-compliance, in view of reducing the administrative burden at the industry, administration and Commission level.
 
Another useful tool is the Good Practice for Market Surveillance guide, published by the European Commission in January 2017. This is a guidance document, aiming to facilitate effective cross border market surveillance and provide a common understanding of the procedures laid down in applicable EU legislation, ensuring a consistent approach to market surveillance at European level. 
 
Corrective actions in case of non-conformity
 
The Blue guide, under section 7.4.5, gives an approach to corrective actions.
 
Note on the term responsible person:
 
In general, market surveillance authorities have legal power to take action only against persons and/or undertakings existing on their national member state territory. Therefore, the term “responsible person” designates the entity, within the national distribution chain of a certain product, against which the national market surveillance authority of a Member State may take legal action.
 
First, there is a dialogue with the responsible person (unless, for example, the product represents a serious and immediate danger to health or safety):
Before any action is taken, the party concerned must be notified and - unless the matter is urgent - given the possibility to be consulted.
 
Second, we speak aboutinvolving the responsible person, who should voluntarily fulfill compliance:
The corrective action depends on the level of non-compliance, which has to be established on a case by case basis, and it has to be in accordance with the principle of proportionality.
First, the manufacturer, or his authorised representative, should be obliged to make the product comply with the provisions of the Directive and to remedy the infringement.
 
Third, we speak about conformity enforcement actions which usually presume activation of the safeguard procedure:
Ultimately, where other measures have failed or they are not considered as sufficient, all appropriate measures shall be taken to restrict or prohibit the placing on the market or making available on the market or putting into service/use of the product in question, and to ensure that it is withdrawn from the market and/or its recall from end-users.
 
Actions taken by national market surveillance authorities in cases of non-compliance must take into account all the circumstances of the case, and must be graduated and proportionate. They must also follow the ways of action foreseen by the national regulations. The national authorities, whilst following, in principle, the above mentioned three steps, may merge or omit some steps, or may move more quickly through a certain sequence of actions.
 
Government Decision no. 306 as of 23 March 2011 on certain measures for market surveillance relating to the products regulated by the European Union legislation harmonising their marketing conditions.