European Personal Protective Equipment Directive 89/686/EEC sets out a new categorization system for PPE products calling under the directive.
News
How long does it take to register a cosmetic product in the EU?
It isn’t always easy to determine just how long it takes to register a cosmetic product for release on the European Market. In some cases it can be a lengthy process, in others quite brief. Read more about it.
Heavy Metals in Cosmetics
Find out what implications EU cosmetics regulations have for the use of heavy metals (zinc, tin, lead, arsenic, cobalt, mercury, etc.) in cosmetic products.
New MDR Conformity Assessment Routes
The approaching EU Medical Device Regulation – which will become applicable on 26 May 2020 – puts great emphasis on the assessment of product safety and performance by placing stricter requirements on clinical evaluation, post-market clinical follow-up and traceability of devices. Thus, the manufacturers worldwide need to perform some crucial adjustments in order to become compliant with the new law.
Game Plan for Upgrading Compliance under Medical Device Regulation 2017/745
Since the introduction of EU Medical Device Regulation 2017/745, manufacturers have been rushing to prepare for it taking full effect on 25th May 2020. The best advice is to start getting ready for the transition now to ensure a smooth process with no negative effects. The first step in getting ready for MDR 2017/745 is understanding what it is and what requirements it has for manufacturers of medical devices. With that in mind, we put some information together to help clear the process up!
SCCS opinion on the safety of cosmetic ingredient Phenylene Bis-Diphenyltriazine
The Scientific Committee on Consumer Safety (SCCS) first assessed the safety of phenylene bisdiphenyltriazine (S86) as a UV filter in sunscreen products in a concentration of up to 10% back in 2015, concluding that it could have genotoxic and phototoxic potential and that an adequate physico-chemical characterization should be provided.
New updates on the state-of-the art thinking on UDI system and database.
Learn more about the new European Unique Device Identifier (UDI) classification system and database introduced under EU Medical Device Regulation 2017/745/EC.
Critical ALERT (!) – EU Official Notice on BREXIT
EU Commission issued an official notice to cosmetics product manufacturers in run up to Brexit. Key items include labelling, notification, and information file.
New version of EN ISO 10993-1:2008
Learn more about the new ISO standards set for evaluating the biocompatibility of medical devices on the European market.
Regulation (EU) 2016/1628 – Pollutant limits in non-road machinery
Find out more about the products and vehicles affected by EU Regulation 2016/1628/EU relating to gaseous and particulate pollutant emission limits in Europe