Industry

Market Surveillance

 

Principles of market surveillance

  • Market surveillance is an essential tool for the enforcement of the New Approach directives of technical harmonization in the European Union.
  • Market surveillance is a national competence.
  • The purpose of market surveillance is to ensure that the provisions of applicable directives are enforced uniformly across the European Union. Citizens are entitled to an equivalent level of protection throughout the single market, regardless of the origin of the product. Moreover, market surveillance is important for the interest of economic operators, because it helps them eliminate unfair competition.
  • Member States must nominate or establish authorities responsible for market surveillance. These authorities need to have the necessary resources and powers/authority in order to carry out the surveillance activities, to ensure technical competence and professional integrity of their personnel, and to act in an independent and non-discriminatory way, respecting the principle of proportionality.
  • In order to avoid conflicts of interest, notified bodies should, in principle, be exempted from the responsibility of market surveillance activities. 

Market surveillance activities

Market surveillance involves two main stages:

  • the national surveillance authorities must monitor whether products placed on the market comply with the provisions of the applicable national legislation which transposes the provisions of the New Approach, and
  • after that, if necessary, take action to bring non-compliant products into conformity.

 

The EC declaration of conformity (DoC) and the technical documentation provide the market surveillance authority with necessary information about the product.

Government Decision no. 740/2016 of 5 October 2016 on making available on the market of radio equipment, which transposes into the Romanian legislation Directive 2014/53/EU (RED Directive), forms the legal framework for ANCOM and ANPC on the market surveillance activity.

In Romania, ANCOM and ANPC are the institutions that have responsibility for implementing the legislation in force in the field of radio equipment and are institutions responsible for surveillance and control activities of radio equipment market. ANCOM surveillance and control activity regards only the compliance of radio equipment made available on the market and those belonging to end users-legal persons. ANPC surveillance and control activity regards only the compliance of radio equipment belonging to consumers (end-users-natural persons).

Market surveillance, inspection of radio equipment and spectrum monitoring provide information on the proper use of the radio spectrum. Each of these activities have specific objectives.  Nevertheless, there is an overall objective and, due to the implementation of the  Directive 2014/53/EU, these elements have become increasingly connected with each other. Information obtained during radio equipment inspection and radio spectrum monitoring, for instance, can form a basis for analysing the market and planning market surveillance activities.

As mentioned above, market surveillance falls within the measurements 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 01.01.2010 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 (abbreviated Regulation on Accreditation and Market Surveillance) which contains requirements for market surveillance organisation, operation and collaboration.

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 about involving 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 2011establishing some measures regarding the market surveillance in relation to the products regulated by the European Union  legislation harmonising their marketing conditions