Jessica Koffel

Jessica Koffel

Associate
Brussels

Email [email protected]​hoganlovells.com

Phone +32 2 505 0911

Fax +32 2 505 0996

LanguagesEnglish, French

Practice groupGlobal Regulatory

Jessica Koffel, a Belgian-qualified lawyer, advises clients on European Union and national regulation of medical devices, medicinal products, EU regulations on chemicals as well as, product safety and product liability issues.

In the life sciences area, Jessica assists clients with the regulatory requirements governing the lifecycle of products, from development stages, to the application process for marketing authorisation of medicinal products, the conformity assessment process for medical devices and related post-marketing activities. She also assists clients in understanding the requirements that will be introduced by the forthcoming entry into application of the new EU medical device regulations and in various aspects of digital health technologies.

In the chemicals area, she helps clients navigate the requirements of the REACH and CLP Regulations and with questions regarding dangerous substances under EU OSH legislation. Jessica further helps clients with environmental legislation such as RoHS and WEEE, and has experience counselling clients on product safety and liability issues under the General Product Safety Directive (GPSD) and product-specific legislation, including Pan-European recalls of products.

Education and admissions

Education

Master of Laws (LL.M.), Maastricht University, 2018

Master of Laws, 2016

Bachelor of Law, 2013

Bar admissions and qualifications

Brussels

Representative experience

Assisted clients with litigation before the CJEU and the ECHA BoA through the introduction of appeals against ECHA decisions on substance qualifications and testing proposals.

Contributed to drafting an EU Commissioned impact analysis Study on the modernising of EU OSH chemicals legislation (CAD/CMD) with a particular emphasis on reprotoxic chemicals.

Provided decisive technical support to a pharmaceutical company on EU product qualifications before a Belgian national court which led to the dismissal of the case.

Led the regulatory compliance analysis of a cosmetic company's product labelling and claims in a 10-figure acquisition project.

*Matter handled prior to joining Hogan Lovells.

Loading data