The Federation of European National Collection Associations (FENCA) lists some of the characteristics of an EU directive: in order to exercise the Union`s competences, the institutions adopt regulations, directives, decisions, recommendations and opinions. When the MDR enters into force, its impact and scope will differ from those of the existing Directive. To understand how the MDR differs from its predecessor and clarify the different types of EU legislation, let`s take a closer look at EU directives and regulations. In terms of regulation, Europe states that « a regulation is a binding piece of legislation. It must be fully implemented throughout the EU. For example, when the EU wanted to protect the names of agricultural products from certain regions such as Parma ham, the Council adopted a regulation. Since directives offer freedom in transposition, the same directive can be applied in the Member States through different approaches. In some EU countries, failure to comply with the standards set out in a directive can lead to fines, while in other countries, violations of the directive can result in prison sentences. Regulations take precedence over national laws and are applied uniformly throughout the EU. An EU directive is more of an order issued to establish policy, assign responsibilities, set objectives and/or delegate powers. A directive can define or describe a policy, program and/or organization. The EU Directive lists the specific objectives that must be achieved in each Member State. The responsibility for achieving the objectives lies with the national authorities, but how they will achieve them is in their hands. In addition to the objectives, the EU Directive will also indicate the date by which the stated objectives are to be achieved.
Regulations and directives are both legal acts of the European Union, but they are implemented and enforced in different ways. Take, for example, EU legislation on the safety of medical devices. Directive 93/42/EEC is replaced by Regulation 2017/745 on medical devices (read more about the official date of implementation of the MDR here). A regulation has general application. It is binding in its entirety and directly applicable in all Member States. The description of the regulations can be found in Article 288 of the Treaty on the Functioning of the European Union (former Article 249 of the EC Treaty). Europe also stresses that regulations are different from directives because, although directives are addressed to national authorities, who must then take steps to incorporate them into national law, this is not the case with regulations. Regulations are laws and national governments themselves do not have to take steps to implement EU rules. Regulations simply have to be followed by every citizen as a law. Regulations can be adopted by the European Commission or jointly by the Council of the EU and the European Parliament. Attention to detail Because of their extensive consequences and authority, settlements are made after careful consideration and taking into account all factors that influence or will be affected by regulations. In addition, the regulations have several subclasses.
Policies don`t require as much care to create them. They are loosely based on the instructions sent to the Member States. Although a regulation has, in principle, direct effect, the Belgian Constitutional Court has ruled that international institutions such as the EU cannot depart from national identity as defined in the country`s fundamental political and constitutional structures, nor from the fundamental values of constitutional protection. [4] While a directive is more of a list of orders for the objectives to be achieved, a regulation is a rule, a law. It is a legally binding force that must be followed and respected in each Member State, like any other national legislation. When a Regulation enters into force, it repeals all national laws relating to the same subject matter and subsequent national legislation must comply with the Regulation and be adopted in the light of the Regulation. While Member States are prohibited from concealing the direct effects of the rules, it is customary to adopt legislation dealing with monitoring issues arising from the entry into force of a regulation. Directives and regulations are two forms of legislation that can be adopted by the European Union. According to Europa, the official website of the European Union, « a directive is a legislative act that sets a goal that all EU countries must achieve. However, it is up to each country to decide how.
This was the case with the Working Time Directive, which states that too much overtime is illegal. The directive sets minimum rest periods and a maximum number of working hours, but it is up to each country to draw up its own laws on how to implement them. The main objective of a directive is to harmonise the different national rules and legislation. An EU directive adopted by all Member States will ensure that all Member States have the same guidelines when dealing with each other, in particular with regard to an internal market, such as product safety standards. Regulations are, in a sense, synonymous with `acts of Parliament` in the sense that what they say is law and do not need to be transposed into national law by implementing measures. As such, regulations are one of the most powerful forms of European Union law, and great care must be taken in their drafting and wording. A directive binds each Member State of destination as to the result to be achieved, but leaves it to the national authorities to choose the form and means. A « regulation » is a binding piece of legislation. It must be fully implemented throughout the EU.
For example, when the EU wanted to ensure that there were common safeguard measures for goods imported from outside the EU, the Council adopted a regulation.