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OBELIS' NEWSLETTER

UK’s Guidance on 3D printing of medical devices or component parts during the pandemic

What is the advice of the UK competent authorities for the manufacturers of 3D-printed devices or components?

Medical | PPE

Personal protective Equipment and Medical Devices in the Covid-19 context - how can they be lawfully placed on the EU market?

If you are interested in selling, buying or using PPE or MD, yet you are unfamiliar with the regulated sectors of PPE and MD in the EU, then this article is for you.

Medical | PPE

AEMPS Information about market campaign control for sunscreen products

The Spanish Agency for Medicines and Health Products (AEMPS) started a market control campaign for sunscreen products, to guarantee that the sun protection factor (SPF) conforms to the one claimed in the labeling.

Cosmetics

Simplification of conformity procedures for CoViD-19 Pandemic-relevant products in Portugal

The Portuguese government has published legislation aimed at increasing the availability of Covid-19 pandemic-relevant products.

Medical

Free Sales Certificates needed for medical device registration in Bosnia and Serbia

These EU standards are then fully accepted and welcomed as the best possible ones also outside the European Union, typically as an official proof of compliance or generally to clear the Customs.

Medical

Faster access of IVDs on the French market

In the context of the health emergency in France due to the COVID-19 pandemic, a Decree was issued in order to ensure a bigger availability of COVID detection tests to the laboratories.

Medical

Regulatory requirements for medical face masks – European Commission Guidance

In the context of the COVID-19 pandemic, the European Commission has published a guidance document concerning the regulatory requirements for medical face masks in support of their production and/or placing on the market.

Medical | PPE

BLOGPOSTS »

Francesca Zuccarello Cimino #BREXIT

Update - Brexit transition- what about IP rights?

The European Commission issued a readiness notice on June 25th 2020, to provide further guidance on what will be the terms of the regulation of IP rights after the end of the transition period.