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?
Other Industries
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.
MDR in few words
A brief overview of the best path for ensuring full compliance with MDR 2017/745 and the implications it has for medical device manufacturers in Europe.
Upcoming event: RMD + CRCC 2019 in Brussels
Obelis invites you to its 4th ERPA Annual Congress on Regulations and Compliance for Cosmetics and EAAR Annual MDR Conference on October 28-29, 2019.
French Competent Authority bans various types of breast implants linked to cancer
French competent authority Agence Nationale de Sécurité de Médicament et des Produits de Santé ban breast implants linked to anaplastic large cell lymphoma.
Obelis new interdepartmental organization
Obelis announces re-organisation of departmental structure in ongoing expansion for greater skill development and improved career path transparency.