As a manufacturer, importer or distributor of medical devices, you are subject to a complex legal framework consisting of both European and national regulations. The same applies to the distribution of your products.

The European Medical Device Regulation (MDR), which entered into force in 2017 and has applied since 2021, raises a number of new legal and regulatory issues for manufacturers, for example with regard to the classification and labelling of products, conformity assessment procedures and clinical evaluations.

I am happy to assist you with all legal matters relating to medical devices.

• Support with market access, including conformity assessment and certification procedures as well as reimbursement matters
• Support in ensuring compliance with legal and regulatory requirements in an ever-changing regulatory environment
• Compliance with and consideration of industry-specific codes of conduct
• Management of product recalls and product liability cases
• Clarification of classification and borderline issues involving medicinal products, biocidal products, cosmetics and combination products
• Legal advice on advertising activities, product presentation and labelling, as well as requirements concerning the content of instructions for use
• Legal Representation