Blog - Page 8 of 13 - Die Produktkanzlei

17. January 2022 Prof. Dr. Boris Handorn

What’s changing in 2022: Life Sciences

The year 2022 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 medical device and medicinal products law.

12. January 2022 Dr. Gerhard Wiebe

What’s changing in 2022: Product-related IT and AI regulation and Product Liability Law

The year 2022 will bring numerous legal changes for affected economic actors in all areas of law in which we specialize as Produktkanzlei. This article focuses on product-related IT and AI regulation as well as product liability law.

11. January 2022 Dr. Carsten Schucht

What’s changing in 2022: Product safety law

The year 2022 will bring numerous legal changes for affected economic actors in all areas of law in which we specialize as Produktkanzlei. This article is related to product safety law.

7. January 2022 Michael Öttinger

What’s changing in 2022: product-related environmental law and supply chain regulation

The year 2022 will bring numerous legal changes for affected business actors in all areas of law in which we specialize as Produktkanzlei. This post marks the start of a series of blog posts entitled “What’s changing in 2022”, in which the respective experts from the Produktkanzlei team summarize the relevant topics from their field in an overview format.

5. January 2022 Martin Ahlhaus

Restriction on the use of tattoo inks entered into force

Already with Commission Regulation (EU) 2020/2081 of 14 December 2020, amending Annex XVII of Regulation (EC) No. 1907/2006 (REACH), a comprehensive restriction of substances in tattooing inks or permanent make-up was introduced. Initially, a transitional period still applied to the use of corresponding mixtures. However, after 04.01.2022, affected mixtures may no longer be used for tattooing purposes.

16. December 2021 Prof. Dr. Boris Handorn

New Implementing Regulation as regards electronic instructions for use of medical devices – just old wine in new bottles?

On 15.12.2021, the Implementing Regulation (EU) 2021/2226 laying down detailed rules for the implementation of Regulation (EU) 2017/745 with regard to electronic instructions for use of medical devices was published.

8. December 2021 Dr. Carsten Schucht

Proposal for uniform charging cables at EU level

On 23.09.2021, the EU Commission published a proposal to amend Directive 2014/53/EU (Radio Equipment Directive). This proposal aims to limit the fragmentation for charging interfaces and charging communication protocols, to improve consumer convenience and to reduce electronic waste.

30. November 2021 Martin Ahlhaus

REACH: New authorization requirements for certain phthalates in medical devices, food contact materials and packaging of medicinal products

With Regulation (EU) 2021/2045 (OJ EU L 418, 24.11.2021, p. 6), the EU Commission has implemented an extension of the entries in Annex XIV to Regulation (EC) No. 1907/2006 (REACH). The four phthalates bis(2-ethylhexyl)phthalate (DEHP, EC: 204-211-0, CAS: 117-81-7), benzyl butyl phthalate (BBP, EC: 201-622-7, CAS: 85-68-7), dibutyl phthalate (DBP, EC: 201-557-4, CAS: 84-74-2) and diisobutyl phthalate (DIBP, EC: 201-557-4, CAS: 84-74-2) have already been subject to authorization obligations.

25. November 2021 Michael Öttinger

Coalition Agreement of the “Ampel” – Impact on product law

On 24.11.2021, the coalition agreement of the new German Federal Government consisting of SPD, BÜNDNIS 90/DIE GRÜNEN and FDP with the title “Mehr Fortschritt wagen – Bündnis für Freiheit, Gerechtigkeit und Nachhaltigkeit” was published. Concrete product law topics are mainly expressed with regard to the IT sector, sustainability and consumer protection.

16. November 2021 Michael Öttinger

New exemptions added to Annex IV RoHS

On 15.11.2021, three Delegated Directives were published in the Official Journal of the EU, introducing three new exemptions from the substance restrictions of Directive 2011/65/EU (RoHS) with retroactive effect to 21.07.2021. The new exemptions relate exclusively to medical devices.