News

Food Supplements Services launch!

Obelis service development department, is honoured to introduce a new regulatory area within Obelis consultancy and regulatory services!Food supplements are regulated under EU legislative framework as foodstuff. The Directive 2002/46/EC defines food supplements as ‘’ foodstuffs the purpose of which is to supplement the normal diet and which

MDR and IVDR Corrigenda published by the EU

The first corrigenda to MDR and IVDR have been discussed and released by the European Union. Some of the corrections changed the MDR and IVDR formally, whilst some others intervened on the content of the Regulations. No major changes occurred with regards to timelinesfor Medical Devices and In Vitro Diagnostics

‘Free from’ claims - clarification of application

The sub-working group on claims released the updated Technical document on cosmetic claims in July 2017. The document serves as a collection of best practices and aims at providing guidance for the application of Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used

Biocompatibility: MDR and EN ISO 10993-1:2018

The medical device industry in Europe will experience a major change in the upcoming years due to the implementation of the new Medical Device Regulation (MDR), to become applicable in May 2020.The biocompatibility of materials will be a principal challenge to be faced. The compliance with the MDR will

Cosmetic Products Regulation 1223/2009/EC Annexes update

We would like to inform you that a new regulation has been published to amend Annexes II, III and V of Regulation (EC) No 1223/2009 on cosmetic product.The new regulation comes into force effective 10th of June 2019 with EEA impact.What are the changes that the new

PPE Regulation 2016/425 – end of transition period

As of 21 April 2019, only Personal Protective Equipment in conformity with PPE Regulation 2016/425 can be placed on the market as foreseen by the transitional period (article 47) of the PPE Regulation.Therefore, it will be no longer possible to place on the market  products in compliance with

NB-MED Performed a survey on IVDR Readiness of the Notified Bodies.

The NB-MED recently published the results of a survey performed between 2018 and January 2019 on the applications of Notified Bodies to be designated under the IVDR.Among the 37 Notified Bodies, currently only 19 are designated for IVDD; most of them have up to 50 Certificates each. The survey

Cannabidiol update in CosIng under the EC Cosmetics Regulation 1223/2009/EC

Time for an update on CannabidiolUse of cannabis in cosmetic products is getting more and more diffused. It is easy to spot numerous advertisements on these products, especially for products containing cannabidiol, but a lot of confusion persists on many different levels, from manufacturers to consumers. Therefore, we decided to