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 for medical device safety. The Directive 93/42/EEC will be replaced by the Medical Device Regulation 2017/745 (read more about the official MDR implementation date here).
When the MDR comes into effect, its impact and scope will differ from 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.
Features of EU Directives
An EU directive is a legal act which requires member states to accomplish a particular set of goals without dictating the means to do it. In other words, it outlines certain rules which must be met, but each member state decides how to ensure compliance through national laws. Directives specify an exact date by which they must be implemented (or transposed) into national law. This is normally two years after their publication in the Official Journal, but can be longer for some criminal law instruments.
An example is the Medical Device Directive (MDD). The MDD outlines the EU requirements for the safety and performance of medical devices. Before placing a medical device on the European market, a manufacturer is legally required to have met the standards outlined in the MDD and applied the CE marking to their product.
While all medical devices sold in the EU must meet the standards outlined in the MDD, each member state has its own set of rules and penalties for how to ensure compliance. When a product falls under the scope of this directive, it is therefore important to consider the relevant national legislation as well as the directive itself.
Features of EU Regulations
Regulations are binding legislative acts that have direct implications for all member states. They are applied in their entirety across the EU, meaning that they are directly applicable in every member state and can be immediately enforced through law like any piece of local legislation. Regulations are equally pertinent to every member state of the EU.
Take the Medical Device Regulation as an example. The MDR will not need to be transposed into national law- the information provided in the regulation itself provides a uniform set of standards for medical devices which must be met across the European Union. This is also why companies must ensure that they comply with the MDR before it comes into force. There is no leeway or grace period for regulations (to learn more about compliance with the MDR, click here).
Key differences between Directives and Regulations
With directives, member countries get more leeway to implement the subject matter of the legislative act. They can work at their own pace to finetune the means of implementation and other necessary legislative actions.
Regulations are more direct, inflexible pieces of legislation. No further deliberations are needed, or allowed, regarding the implementation of EU regulations. They come into effect as soon as they get ratified by the EU parliament. In their legislative power, regulations are unparalleled to any other constituent of EU law. Directives don’t have the same stature of legislative power.
Attention to detail
Because of their far-reaching consequences and authority, regulations are finalized after rigorous thought processing and by taking care of all the factors that affect the regulations or will be affected by them. Moreover, regulations have multiple subclasses. Directives don’t involve so much painstaking in their creation. They are loosely based on the instruction conveyed to the member states.
Degree of their effect
As mentioned earlier, regulations are rolled out for each and every member state of the EU. Usually, directives are also applicable to every EU country, but sometimes they can be addressed to a single EU member state or a select group of them.
Different approaches for implementation
Since directives provide liberty regarding their implementation, the same directive can be enforced in member states through different approaches. In some EU countries, a failure to meet the standards outlined in a directive can result in fines, while in other countries directive violations can lead to imprisonment. Regulations overrule national laws and are enforced uniformly throughout the EU.
Keep in mind…
The CE marking process differs for every product, and products often fall under the scope of multiple directives and/or regulations. For example, moving x-ray machines or electrically powered hospital beds are considered both medical devices and machinery, and must therefore comply with both the MDR and the machinery directive.
If you have questions about EU legislation or are unsure which regulations or directives are applicable to your product, contact us. By guiding you through the entire CE marking process, we ensure swift market access for products that meet the highest safety standards.