News

Is the Irish health sector prepared for an eventual Brexit?

If you are an Irish undertaking producing or exporting medical devices into the European Union or you are simply willing to extend your market, this article is for you. It is a fact that the Irish Health Products Regulatory Authority is in close cooperation with its correlative Department of Health

Spain is ready for Brexit: new checklist for Medical Devices and Cosmetics

The Spanish Agency of Medicines and Medical Devices (AEMPS) has published a Checklist to verify the Brexit readiness of companies based in Spain in the sector of: Medical Devices: Devices with a Notified Body (NB) established in the UK: manufacturer must ask for a new Certificate from a EU27 NB

New EU Regulation on Market Surveillance and Compliance of Products

A measure aimed at increasing compliance Regulation 2019/1020/EU amends the currently applicable Regulation 765/2008/EC and has the main objective to strengthen the compliance of products on the market. Such a need was highlighted due to the rise in non-conformities of products found on the market. Non-compliance

MDR Transitional regime clarified by MDCG

The Medical Devices Coordination Group (MDCG) has published a document concerning the validity of certificates issued in accordance to the Directive MDD [1] and AIMDD [2] after the new Medical Device Regulation (MDR) becomes applicable. Article 120 (2) of the MDR states that certificates issued in accordance to MDD and

Motor vehicles on the EU market: New Regulation to become applicable in September 2020

A measure aimed at ensuring and monitoring compliance for the automotive industry After multiples scandals involving the automotive industry and its manufacturers, especially with the so-called ‘defeat devices’ (systems used to alter vehicles performance during testing) and the Volkswagen case, the EU decided to intervene and transform the EU type-approval

Cosmetic products and cannabis under the EC Cosmetics Regulation 1223/2009

The rising trend Nowadays, cannabis products are gaining more and more popularity around the world and the same is true for its use in cosmetic products.  As far as compliance is concerned, there are two main issues to take into account: the THC content (which needs to be very low

How will cosmetic products be regulated in the UK in case of a no-deal Brexit?

Preparing for different Brexit scenarios, the UK government published a guidance covering the EU Exit Regulation for Cosmetic Products in case UK leaves the European Union without a deal. While there are many similarities between the EU and UK regulatory regime for cosmetic products, the withdrawal of the UK from

Update on Brexit: Cosmetics

On the 18th of July, the European Commission published a Notice to stakeholders regarding the withdrawal of the United Kingdom and the impact on the EU rules in the field of cosmetic products. Consequences for cosmetic products As of the withdrawal date, which is set so far for the 1st

SCCS minutes made public!

The working groups of the Scientific Committee on Consumer Safety (SCCS) have held meetings recently. The Working Group on Cosmetic Ingredients in Cosmetic Products met on July 16 , when the draft opinion on hair dye Methylimidazoliumpropyl p-phenylenediamine HCl was discussed and finalized. As for the consultation process for the Endocrine

IFRA 49th Amendment coming soon!

IFRA1 will soon release (expected for 3rd quarter of 2019) the 49th Amendment of their self-regulatory system, setting rules for the use of nearly 200 fragrance materials, updating restrictions and prohibited substances. Basic new elements for the IFRA 49th Amendment:         New product categorization: 22 distinct “classes” across 11 “categories” to

EU – USA Cooperation in Medical Devices

During President Juncker’s visit to the White House on 25 July 2019, he stated in a press conference that the EU is currently working to reduce barriers and increase trade in medical products. The industry of medical devices is dominated by the EU and US together. While the US’

Upcoming event: RMD + CRCC 2019 in Brussels

We are proud to announce you that Obelis is organising the 4th ERPA Annual Congress on Regulations and Compliance for Cosmetics (CRCC2019) and the 4th EAAR Annual Conference on New Medical Device Regulations (RMD2019) in Brussels on 28-29 October 2019. We invite you to be  part of these yearly events