Read more on how new EU Medical Device Regulation 2017/745 defines the term “equivalence” and what implications it has for products already on the EU market.
News
NEW VERSION OF THE BORDERLINE AND CLASSIFICATION MANUAL FOR THE MEDICAL DEVICES AND IVDs
European Commission publishes updated version (V1.20) of the Borderline and Classification Manual for medical and in-vitro diagnostics devices on the EU market.
New updates on the Poison Centres website
The Poison Centres website has been updated with new support pages in order to assist the industry to prepare and submit information on hazardous mixtures.
GPSD – steps to compliance
Learn more about the steps to compliance for your product under European General Product Safety Directive 2001/95/EC, from CE certification to the RAPEX system.
Important decrease on the use of plastic micro beads on cosmetic products
Read more on the increasing concern on this plastic litter in the marine environment that can harm ecosystems.
Find out what decisions the EU will take.
ECHA: EU investigates permanent cosmetics and tattoo inks
The ECHA has been conducting studies into harmonizing EU tattoo and permanent make-up safety processes and legislation across Europe.
Registration of medical devices in Slovakia
Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive (93/42/EEC). While this Directive is a law to all 28 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation. An example of such local implementation of the Directive is now present in Slovakia. Read more here.
Obelis UK Ltd established!
Obelis announce new Obelis UK Ltd to provide services for cosmetics manufacturers requiring a UK Responsible Person in the case of a 'no deal' Brexit.
Impact of the New Cosmetics Regulation
The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) has been in place for over three years since it replaced the old EU Cosmetics Directive 76/768/EEC. The regulation was introduced with the express purpose of simplifying and harmonizing the regulatory requirements across all member states while also upgrading the requirements placed on the Brand Owner. Read more about it.
How Much Does CE Marking and Certification Cost?
How much does CE Marking and Certification cost? Find out more about this topic here.