Read more about the opinion of the European Data Protection Supervisor holds for the implications of GDPR on clinical research conducted within the EU.
Other Industries
The European Commission has published a FAQ document on UDI
Throughout the many changes the EU Medical Device Regulations 2017/745 and 2017/746 will bring, one equally important is the introduction of a device traceability system based on Unique Device Identification, most commonly mentioned as UDI, within the healthcare supply chain. Read more about it here.
Danish competent authority bans phthalates and boron releasing toys
As squishy and slime toys are becoming increasingly popular among children, many EU member states have been strengthening inspections for harmful chemicals in their composition.
Type-approval for vehicles: Revised General Safety Regulation enters into force
As of July 2022, the new rules require all vehicle models introduced on the European market to be equipped with advanced safety features.
Second Corrigendum to the MDR: A Christmas gift for manufacturers
The second corrigendum to Regulation (EU) 2017/745 on medical devices has brought a change in the wording of certain part of articles 78(8), 120(3), 120(4), 120(8) and 122; but what does it imply for the concerned economic operators?
New EU Regulation on Market Surveillance and Compliance of Products
The new Regulation sets out an obligation for economic operators to cooperate with the market surveillance authorities and establishes a framework for the control of products entering the Union market.
Motor vehicles on the EU market: New Regulation to become applicable in September 2020
Find out more about the technical requirements and approval process for motor vehicles under EU regulation 2018/46/EC entering effect in September 2020.
Cosmetic products and cannabis under the EC Cosmetics Regulation 1223/2009
Guidelines for the use and inclusion of cannabis and cannabidiol products within cosmetics on the EU market under EC regulation 1223/2009.
MHRA Guidance on Assistive Technology: medical device or not?
Products that assist and support individuals with disabilities, restricted mobility or other conditions to perform functions that would be difficult to perform without such products are known as ‘Assistive Technology’.Classifying these products is not an easy task as they might be a medical device or an ‘aid for daily living’. Read more about it.
The CPNP Notification Process – Step by step
A simple guide to bringing your cosmetics products though the Cosmetics Products Notification Portal for total European Market compliance.