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For the medtech sector, 2023 will be dominated by extended transition periods for the Medical Devices Regulation (EU) 2017/745 and other administrative measures to ensure that the regulatory bottlenecks at notified bodies that have been apparent for a long time do not become real bottlenecks in the supply of medical devices to patients. And of course, 2023 is also dominated by digitalization – complementing our article, we take a sector-specific look at the planned European Health Data Space.

The year 2023 will bring numerous legal changes for affected economic actors in all areas of law in which we specialize as Produktkanzlei. This article focuses on essential new regulations in chemicals law.

The increasingly rapid pace of product-related regulation at national and European level is unstoppable. Companies should therefore keep abreast of changes in the law that has already been adopted and affect them, as well as of ongoing and emerging developments. This is the only way to ensure compliance with current regulations and to be able to influence future regulations.

The increasingly rapid pace of product-related regulation at national and European level is unstoppable. Companies should therefore keep abreast of changes in the law that has already been adopted and affect them, as well as of ongoing and emerging developments. This is the only way to ensure compliance with current regulations and to be able to influence future regulations.

In 2023, legal practice will naturally focus in particular on the analysis of the legal acts on product safety that have recently been enacted or will be enacted in the near future. In this respect, it will be important to set the necessary internal course in order to continue to be able to legally manufacture, import and distribute the non-food products covered in each case in the European Union (EU). Of overriding importance is undoubtedly the new Product Safety Regulation, which was (provisionally) adopted at the end of 2022 and will soon replace the General Product Safety Directive of 2001.

The increasingly rapid pace of product-related regulation at national and European level is unstoppable. Companies should therefore keep abreast of changes in the law that has already been adopted and affect them, as well as of ongoing and emerging developments. This is the only way to ensure compliance with current regulations and to be able to influence future regulations.

With a delay of a good year, the EU Commission published its long and eagerly awaited proposal for a Packaging Regulation on 30.11.2022. Following the self-imposed trend, packaging law is also to be transformed from waste to life-cycle regulation and harmonised throughout the EU by means of aregulation.

In its session on 25.11.2022, the Bundesrat finally cleared the way to extend the transition period for operators of electronic marketplaces and fulfillment service providers with regard to manufacturer registration under the ElektroG.

The European Court of Justice (ECJ) annulled the classification and labelling of titanium dioxide in powder form under Delegated Regulation (EU) 2020/217.

On 15.09.2022, the Commission published its proposal for a regulation on horizontal cybersecurity requirements for products with digital elements, the “Cyber Resilience Act” (hereinafter “CRA-E”). As the first European legal act of its kind, it will introduce mandatory cybersecurity requirements for products with digital elements throughout their lifecycle.