Your Definitive Guide to CE Marking
Information about the various CE marking directives
The EU MDR (Medical Device Regulation) tends to follow the approach of the US FDA (Food and Drug Administration). In the current situation, it tightens the existing regulatory framework for medical devices in Europe in a way that is unacceptable to many market participants.
Compliance and the growth of the medical industry, does it work together? This question is highly relevant because the growth in the medical device industry is significant. And also, this will continue to be the case for the foreseeable future.
The EU Proposal: New Harmonized Standards for placing Construction Products on the Market is published. This is a short summary of the content of the proposal. You can also find a link to the full draft.
The Netherlands Radiocommunications Agency wants to make citizens aware of the dangers of disruptive and vulnerable electrical and wireless equipment through a public campaign. Devices without a CE mark could potentially cause interference or be unsafe.
Dyson’s claim for compensation for loss due to unlawful EU legislation was dismissed by EU General Court. The Vacuum cleaner manufacturer has now said that it will appeal against this ruling. Read about it here.
UK Reach: Deadline extended. The UK government will consult on whether or not to extend the deadlines to october 2025 for submitting the full registration data.
Amendments Pressure Equipment Directive 2021 Harmonized Standards. Read about the amendments and revisions made by CEN here.
The European Commission confirms: it is preparing a proposal to postpone the implementation of the Medical Device Regulation (EU) 2017/745 with one year.