SELECTION OF LEGAL UPDATES
EUDAMED: European Database on Medical Devices
EUDAMED (European Database on Medical Devises) is a system developed by the European Commission for the implementation of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It represents a significant innovation introduced by these regulations.
The database serves as a centralized registry of all medical devices available on the EU market, their manufactures, importers, certificates, and safety reports. A large portion of this information will also be accessible to the public.
As of 28 May, the use of the first four modules is mandatory for entities to registration obligations under MDR and IVDR:
- Registration of economic operators
- UDI and medical device registration
- Notified bodies and certificates
- Market surveillance
- Obligations for entities
The introduction of EUDAMED brings new obligations for individual economic operators. Manufactures will bear the greatest number of obligations, as they must register themselves and their devices and fulfil additional reporting duties. Importers and authorized representatives primarily have registration and control roles.
- What will change?
The introduction of the database also transforms the Czech system of medical device registration. The Information System of Medical Devices (ISZP) will newly use data from EUDAMED, enabling uniform identification of devices and simplifying procedures for distributors. The aim is to increase transparency, support market surveillance, and align Czech processes with the European regulatory framework.
Uber drivers and Wolt couriers may obtain employee status
A significant change is expected in the field of labour law. EU Member States are required to transpose Directive (EU) 2024/2831 of the European Parliament and of the Council on improving working conditions in platform work into their legal systems.
The Czech Republic will do so through a new Act on Platform Work, a draft of which has been prepared by the Ministry of Labour and Social Affairs.
According to the current draft, amendments to the definition of dependent work and the introduction of a rebuttable presumption of the existence of an employment relationship are under consideration.
- New definition of dependent work
The Act on Platform Work changes the definition of dependent work, which is to be based primarily on a relationship of subordination and performance of work on behalf of the employer. Certain existing characteristics are moved to implementing provisions, where they are elaborated in more detail (e.g. organization of work, supervision, and performance during working hours). However, the requirement of personal performance of work has been removed from the defining characteristics, which may be inconsistent with existing case law and practice.
- Rebuttable presumption of an employment relationship
The rebuttable preumption provides that if facts exist which reasonably indicate that the characteristics of dependent work have been fulfilled, a platform worker is presumed to be in a basic employment relationship. This legal presumption applies in all administrative and judicial proceedings (with the exception of criminal proceedings) and during inspections where the contractual status of the platform worker is assessed. The Act on Platform Work should thus bring a higher degree of legal certainty for individuals performing this type of work.
PPWR: Packaging and packaging waste regulation
Regulation (EU) 2025/40 of the European Parliament and of the Council on packaging and packaging waste will enter into force on 12 August 2026. Its main objective is to prevent the generation of packaging waste and reduce the environmental impact of packaging.
The PPWR sets requirments in particular for:
- environmental sustainability of packaging
- packaging labelling
- reuse of packaging
- prevention of packaging waste generation
From 2030, certain categories of single-use plastic packaging defined in the PPWR will be banned.
The packaging label must indicate the share of recycled materiál content and the relevant waste containers designated for the collection of packaging waste.
Another objective of the Regulation is the minimisation of packaging. Packaging must be designed so that its weight and volume are limited to the minimum necessary while maintaining its protective function. The Regulation prohibits double walls, false bottoms, and unnecessary layers.
It is expected that the introduction of the PPWR will lead to a reduction in packaging waste, more efficient use of materials, higher recycling rates, and broader opportunities for the use of reusable packaging instead of single-use solutions.
ICC Arbitration Rules 2026: What changes do the new rules bring?
The new Arbitration Rules enter into force on 1 June 2026. Their main objective is to improve the efficiency and speed of arbitral proceedings.
The most significant changes include:
- abolition of the obligation to prepare Terms of Reference (definition of the issues in dispute)
- introduction of a so-called Highly Expedited Arbitration Procedure (HEAP)
- increase of the financial threshold for expedited proceedings to USD 4 million
- introduction of the possibility of early determination of manifestly unmeritorious claims
The new rules build on the 2021 revision and introduce further changes aimed at eliminating unnecessary delays, increasing procedural efficiency, and better adapting arbitration proceedings to the needs of the parties to the dispute.
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