The Treaty of Lisbon was the most ambitious EU project until its date of entry into force in 2009. The main purpose of the new treaty was to further deepen European integration, acquire new conferred powers, reinforce the European Economic Area, and enlarge its legislative scope.
Novel policy areas emerged as a result of the treaty and quite rapidly started to earn a privileged spot in the policymaking of the Union. However, this fast transformation made some already settled policies be regarded as outdated and in need of an adaptation to the new times. This was, most notably, the case of the Industrial Policy, a legislative framework whose origin draws us back to the early European Coal and Steel Community in 1952.
In 2008, the European Parliament and the Council jointly adopted the Decision No. 768/2008/EC aiming to set a common framework for a new Industrial Policy.
The new legislative framework
The key objective of the Decision was clear: “To improve the internal market for goods and strengthen the conditions for placing a wide range of products on the EU market”. That is, to make the EU Market safer and abundant on high-quality products.
Since 2008, up to 23 legislative acts concerning industrial products have been approved by the EU institutions, with a focus on:
· Improving Market Surveillance to better react before defective products and enhance the protection of the users;
· Setting out clear rules for the accreditation of Notified Bodies;
· Setting out clear rules for the conformity assessment procedure of products by Notified Bodies;
· Clarifying the meaning of the CE Marking;
· Establishing a common legal framework for industrial products to help homogenize the different national provisions of the Member States under a single set of directives and regulations.
What is being done at the current stage?
Most recently, in 2020, the European Commission launched an “Evaluation of the New Legislative Framework” (NLF), involving the opinions of national authorities, manufacturers, distributors, importers, Notified Bodies, and consumer organizations. Digital and green transformation was also at the core of the discussion.
With a roadmap defined by the European Commission at the end of 2020, now the public consultation with the above-mentioned stakeholders is open until March 7, 2022.The Evaluation is planned to be adopted in the second quarter of 2022. The Evaluation aims to recognize and adapt to new market trends, including intelligent devices that might be constantly changing due to, for instance, software updates and Artificial Intelligence, as well as remanufactured products in the context of a growing circular economy. Furthermore, the European Commission aims to survey the resilience that the market may have on future crises, taking into consideration what has been learnt from the COVID-19 pandemic.
Which sectors will be affected?
It is rather clear that the creation of the so-called “European Union of Health” has become a major endeavor for the European Commission following the COVID-19 crisis. With the Medical Devices Regulation (2017/745/EU) and the In Vitro Diagnostics Regulation (2017/746/EU), which belong to the NLF, playing an important role.
A non-extensive list of other relevant pieces of legislation that will be considered in the Evaluation include several New Approach Directives such as:
– Toy Safety Directive (2009/48/EU)
– Electromagnetic Compatibility Directive(2014/30/EU)
– Low Voltage Directive (2014/35/EU)
– Radio Equipment Directive (2014/53/EU)
– Pressure Equipment Directive (2014/68/EU)
– Personal protective equipment Regulation(2016/425/EU)
Are you manufacturing any of the above products and do you wish to market them in the EU? Contact us today.
Alvaro Mercado Ortega
Regulatory Affairs Department
· European Commission (2021). European Health Union. Protecting the health of Europeans and collectively responding to cross-border health crises. Retrieved on 23/02/2022 from https://ec.europa.eu/info/strategy/priorities-2019-2024/promoting-our-european-way-life/european-health-union_en
· European Commission (2021). Evaluation roadmap. Evaluation of certain aspects of the New Legislative Framework (Decision No 768/2008/EC and Regulation (EC) No 765/2008). Retrieved on 23/02/2022 from https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12654-Industrial-products-evaluation-of-the-new-legislative-framework_en
· European Commission (2021). Industrial products – evaluation of the new legislative framework. Retrieved on 23/02/2022 from https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12654-Industrial-products-evaluation-of-the-new-legislative-framework_en
· European Commission (2021). New legislative framework. Retrieved on 23/02/2022 from https://ec.europa.eu/growth/single-market/goods/new-legislative-framework_en
· European Parliament (2021). Treaties and the European Parliament. Retrieved on 23/02/2022 from https://www.europarl.europa.eu/about-parliament/en/in-the-past/the-parliament-and-the-treaties