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.

Subsequently, by the publication of the Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011, many of the articles under Regulation (EC) no.765/2008 have been eliminated, several amendments have been brought to the remaining articles, and the title has been changed. The most relevant change from the viewpoint of market surveillance was the elimination of the entire Chapter III “Community market surveillance framework and controls of products entering the community market”, which dealt with the field of application, community market surveillance framework, risks, restrictive measures, exchange of information, controls of products entering the community market, and cooperation principles, all of which now fall under the Regulation (EU) 2019/1020.

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 Chapter 7, gives an approach to corrective actions, as part of the controls carried out by the market surveillance authorities.

The economic operators have clear obligations to cooperate with the national market surveillance authorities and take corrective actions, when necessary.

The national market surveillance authorities shall take appropriate and proportionate measures in order to make sure that unsafe products or products which, for any other reason, are not compliant with the applicable requirements under the EU harmonisation legislation, are prevented from entering the community market or are withdrawn from the market. Where legal provisions are breached, the authorities shall have competence to apply adequate sanctions, proportionate with the respective breaches, and, especially in case of serious or repeated offences, with a dissuasive effect.

Non-conformity to essential requirements must generally be considered as a substantial non-compliance, because this may lead to the product presenting a potential or actual risk to the health and safety of the persons or to other aspects of public interest.

First, regarding the procedure to be applied in case of a non-compliant product or in case of a product which represents a risk for the health and safety of the persons or for any other issue related to protecting the public interest, there is a dialogue with the relevant economic operator (except for an emergency case related to health, safety, or other grounds relating to the public interest):

The market surveillance authorities must first contact the relevant economic operator, informing it about the findings and giving it the opportunity to provide its view.

Second, we speak about involving the responsible person, who should voluntarily fulfill compliance:

The authorities require the relevant economic operator to take appropriate and proportionate corrective action in order to bring the non-compliance to an end or to eliminate the risk. The possible actions range from rectifying formal non-compliance to withdrawing or recalling the products, they have to be in accordance with the degree of risk or non-compliance, and their impact on the free circulation of products may not go beyond what is necessary for achieving the market surveillance objectives. In case of serious risk, a different approach may apply.

Economic operators must ensure that the corrective action is taken throughout the EU. If the non-compliance or risk relates only to part of a series of products manufactured that can be reliably identified, only that part needs to be addressed. If there eis a doubt about either the risk being limited to a certain part or the reliable identification of that part, the corrective action should concern all the products/series. For an isolated error, limited to the territory of the Member State that has discovered the non-compliance, there is no need to take action throughout the EU.

Market surveillance authorities have to verify that corrective action has been taken. If an economic operator does not take adequate corrective action within the period indicated by a market surveillance authority, the market surveillance authorities have to take appropriate measures to prohibit or restrict the making available of the product on their national market, to withdraw the product from that market, or to recall it.

Third, we speak about conformity enforcement actions which usually presume activation of the safeguard procedure:

Products deemed non-compliant in one Member State are generally presumed to be non-compliant across the EU. Cooperation and coordination of action among national authorities is indispensable to obtain effective and consistent surveillance of the Internal Market.

Action against products found to be non-compliant has to be generally undertaken throughout the EU, with detailed procedures in the case of certain Union harmonisation legislation which includes a safeguard clause.

Also, Section 7.6.2.4 of the Blue Guide provides an approach as to products which are compliant with the essential requirements but which still present a risk. Union harmonisation legislation generally foresees the possibility of, and requires for action to be taken against, products which are compliant with the essential requirements but which still present a risk. Where the market surveillance authorities find that a product, while being compliant with the applicable Union harmonisation legislation, presents a risk to the health or safety of persons or to other aspects of public interest protection, they must take measures to require the economic operator to ensure that the product no longer presents that risk, to recall it or to withdraw it, depending on the risk. As soon as a market surveillance authority restricts or forbids the free movement of a product in such way that the safeguard clause is applied, the Member State must notify without delay the Commission and the other Member States of the provisional measures, indicating the reasons and justification for the decision.

Government Ordinance no.20/2023 (in Romanian) on setting measures for the implementation of Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011, as well as for amending and completing certain normative acts