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Getting ready for the EU MDR: Requirements for identification and traceability of medical devices

Eveline Van Keymeulen

In this post of our “Getting ready for the MDR” series, we analyse the most important requirements for device identification and traceability that will be imposed on manufacturers and other economic operators placing medical devices on the EU market. MedTech Europe, the association representing the European medical technology industry, estimates that approximately 500,000 different medical devices Read More

ECJ: organisms obtained by new mutagenesis plant breeding techniques are not exempted from the GMO Directive

Sophie ten Bosch

Today, the European Court of Justice (ECJ) has decided in case C-528/16 that organisms obtained by new mutagenesis plant breeding techniques are genetically modified organisms (GMOs) and subject to the obligations laid down in the GMO-Directive (Directive 2001/18/EC). This decision interprets the GMO-Directive in light of new plant breeding techniques such as CRISPR-Cas9. Mutagenesis is Read More

Dutch Data Protection Agency issues guidance on large-scale data processing in healthcare

Iradj Nazaryar

Last month, the Data Protection Agency (DPA) issued guidance on large-scale healthcare data processing. The General Data Protection Regulation requires organisations involved in large-scale processing of data to appoint a Data Protection Officer (DPO) and in certain cases to conduct a Data Protection Impact Assessment (DPIA). In this respect, the guidance clarifies when healthcare providers are Read More

Revised French Personal Data Protection Act: Constitutional Court upholds health related provisions included in the bill

Laurie-Anne Ancenys

On 22 June 2018, a new law entered into force, after the French parliament amended the personal data protection bill to reflect a decision of the French Constitutional Court. The court had indeed earlier upheld the majority of the provisions of the French personal data protection bill, which amends Act n. 78-17 on Information Technology, Read More

Belgium launches single online portal for health data

Tine Carmeliet

At the initiative of the Minister for Social Affairs and Health Care, on 8 May 2018, the Belgian government announced the launch of a single online portal for health data entitled “MaSanté – MijnGezondheid“. The portal aims to provide citizens with an easily accessible overview of all existing health data (including their personal data) and Read More