-
Breaking news: European Commission published second batch of harmonised standards under MDR
On January 4, the European Commission recognised nine harmonised standards for medical devices that manufacturers can reference in order to satisfy conformity requirements under the Medical Devices Re
5/10/2024More -
Cybersecurity and the Radio Equipment Directive
The Delegated Act to the Radio Equipment Directive (RED) has laid down new legal requirements for cybersecurity of wireless devices.
5/10/2024More -
New Radio Equipment Directive 2014/53/EU
Starting from 13 June 2016 all member states must apply the new Radio Equipment Directive (RED) 2014/53/EU. Check new requirements for affixing the CE marking.
5/10/2024More -
Exemption from RoHS standards has expired for industrial measurement and control equipment
As of 22 July 2017 specific industrial measurement and control equipment must comply with the requirements of Directive 2011/65/EU regarding the restriction of the use of specific hazardous substances
5/10/2024More -
The Toy Safety Directive 2009/48/EC and CE marking
The Toy Safety Directive 2009/48/EC defines the essential safety requirements for toys to comply with before they can be placed on the EEA market. Read all important moments in simple words.
5/10/2024More -
What is a toy according to the Toy Safety Directive 2009/48/EC?
Many products can be used in play by children, but that does not mean that all objects fall under the definition of a toy. The Toys Directive describes what a toy is on the basis of a number of criter
5/10/2024More -
What is NOT a toy according to the Toy Safety Directive 2009/48/EC?
The Toy Directive 2009/48/EC does not cover all products that we can name "a toy". Annex I contains an exhaustive list of products that are not regarded as toys.
5/10/2024More -
Guidance for the EU Authorised Representative and PRRC (MDR 2017/745)
On 31 October 2022, new guidance for the EU Authorised Representative and the Person Responsible for Regulatory Compliance (PRRC) was published. This document is intended for manufacturers, EU Authori
5/9/2024More -
MDR transition period is changed
Begin January, the EU Commission formalized the proposal to update Art. 120, Art. 122 and Art. 123 of the MDR 2017/745. This has been done with intention of giving Notified Bodies (NoBo’s) more time
5/9/2024More