New registration obligation for packaging in Spain

The Spanish packaging law obliges producers to register their packaging. Distributors from abroad must also register through an authorised representative if they sell packaged products in Spain.

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Document titled GPSR with a magnifying glass placed over a warning sign
General Product Safety Regulation (EU) 2023/988 obliges
GPSR Risk Analysis Required

Mandatory for almost every product: According to the GPSR, producers must draw up technical documentation for the products they place on the market. The technical documentation must be based on an internal risk analysis.

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General Product Safety Regulation requires Responsible Person
EU Responsible Person Service for the GPSR and more

Since 16 July 2021, it is against the law to sell products with CE marking without a Responsible Person in the EU. In addition, a Responsible Person must also be specified in accordance with the General Product Safety Regulation (EU) 2023/988.

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Personal EU Batteries Regulation Training
Ready for the new Batteries Regulation (EU) 2023/1542

Find out which obligations the EU Batteries Regulation places on you and how to deal with them in your specific case. Receive comprehensive information on how to implement your obligations with regard to labelling, battery passport, EPR and due diligence obligations in the supply chain.

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Selling medical respiratory masks without CE marks

While so-called “community masks” without the CE mark can be placed on the market, these are not suitable for use in the clinical sector, for instance. However, for medical respiratory masks which are also marketable in the United States of America, Canada, Australia or Japan, Section 11 (1) of the German Medical Devices Act allows the competent authority to issue special permits and, where necessary or applicable, also to declare such masks without CE marks as marketable in Germany.

According to the German Medical Devices Act (Medizinproduktegesetz - MPG), respiratory masks that are to be marketed within this framework must meet the relevant requirements. In particular, they must bear the CE mark.

If the CE mark is lacking, problems may arise with customs, especially when importing such masks into the EU. While so-called “community masks” without the CE mark can be placed on the market, these are not suitable for use in the clinical sector, for instance. However, for medical respiratory masks which are also marketable in the United States of America, Canada, Australia or Japan,  Section 11 (1) of the MPG allows the competent authority to issue special permits and, where necessary or applicable, also to declare such masks without CE marks as marketable in Germany.

Recommendation: Importers of medical respiratory masks affected must comply with the requirements of the Medical Devices Act. Register the products concerned, including the relevant test certificates or foreign approval certificates, for special approval at medizinprodukte@bfarm.de

Trade-e-bility GmbH will advise you on the preparation of the documents for submission. If you have any questions, please do not hesitate to call trade-e-bility on +49/40/75068730-0 or send an e-mail message to beratung@trade-e-bility.de.

Sebastian Siebert
Contact

Sebastian Siebert
Head of Advisory services

Phone: +49 40 750687-0

beratung@take-e-way.de

Christoph Brellinger
Contact

Christoph Brellinger
Head of Marketing & Public Relations

Phone: +49 40 750687-0

presse@take-e-way.de

Services & Contact
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