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Medical Devices

Few regulatory regimes ask as much of a product as the Medical Device Regulation. The MDR governs a device across its entire life cycle — clinical evaluation, technical documentation, conformity assessment and post-market vigilance — and applies alike to a class I wheelchair and a software-driven implant. The real difficulty is seldom any single requirement. It lies in keeping pace with shifting legal requirements, notified body expectations, holding a device compliant across every market in which it is placed, and managing the seams where the MDR meets the horizontal regulations now layered over it, such as the Batteries Regulation and the Packaging and Waste Regulation.

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Our expertise

We advise manufacturers, importers and distributors, alongside authorised representatives and the other economic operators the MDR recognises, as well as health institutions, on products ranging from single-use consumables to complex implantable and AI-driven devices. We know the MDR in depth, and — as importantly — we understand how it interacts with the regimes now converging on it, from the AI Act to product liability. Day to day we work as a hands-on sparring partner for regulatory affairs, legal and quality teams. When a competent authority becomes involved, we step in as external counsel.

How we can help

We advise through the entire development and life cycle of a medical device. Our work usually opens with determining whether a product is a device or not, device classification and a gap analysis against the MDR, followed by a practical roadmap to full compliance. From there we advise on clinical evaluation reports, classification rationales, risk management files and the technical documentation notified bodies expect to see, and we guide you through the conformity assessment procedure itself where needed. Once a device is on the market, we help build or refine post-market surveillance, vigilance and post-market clinical follow-up. When a field safety corrective action or recall needs to be considered, we move quickly — as we do when a competent authority raises questions or opens an investigation. We advise, too, on labelling, on interactions with healthcare professionals and the rules on inducements, and on clinical investigation requirements. And we support hospitals and research institutions that manufacture devices in-house, as well as assessing regulatory exposure in M&A due diligence.

Our medical devices specialists

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Erik Vollebregt

Partner and attorney-at-law

  • Regulatory
  • Litigation
  • Commercial

Carine van den Brink

Partner and attorney-at-law

  • Corporate
  • Commercial & IP

Judith de Wilde

Attorney-at-law

  • Regulatory
  • Commercial
  • Litigation

Max Baltussen

Attorney-at-law

  • Commercial & IP

Cécile van der Heijden

Senior legal counsel and attorney-at-law

  • Regulatory
  • Litigation
  • Commercial

Jilles van der Hoek

Attorney-at-law

  • Regulatory
  • Litigation

Jasmin Buijs

External legal counsel

  • Regulatory

Stijn Gijsbers

Attorney-at-law

  • Regulatory
  • Litigation
  • Commercial

Max Luijkx

Attorney-at-law

  • Corporate
  • Commercial

Inga Szweryn

Attorney-at-law

  • Corporate
  • Commercial
  • Regulatory

Karin Verzijden

Partner and attorney-at-law

  • Regulatory
  • Commercial & IP
  • Litigation

Menno Knaven

Attorney-at-law

  • Corporate
  • Commercial

Maartje Hop

Attorney-at-law

  • Regulatory
  • Commercial & IP

Recent

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Food and Feed Medical Devices Pharmaceuticals Due Diligence Testimonial

Axon regularly acts as a sub-contractor for leading international firms to assist in regulatory due diligence in our fields of expertise: pharma, medical technology and food.

Medical Devices Regulatory Compliance and Enforcement Testimonial

We have provided in-house training for the authorised representative of a large multinational on its obligations under the MDR.

Medical Devices Regulatory Compliance and Enforcement Spin-out and Starter Advisory Testimonial

We have advised a start-up on enforcement actions brought by the Dutch Healthcare Inspectorate (IGJ) concerning MDR compliance.

Medical Devices Regulatory Compliance and Enforcement Testimonial

We have assisted a manufacturer of medical devices in obtaining a derogation from conformity assessment procedures under the MDR in the interest of public health.

Medical Devices Data Protection, (Cyber)security and AI Testimonial

We have advised a medical device manufacturer on collaborations with academic institutions on data collection for training of AI systems, including the necessary data protection contracts.

Medical Devices Data Protection, (Cyber)security and AI Testimonial

On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.

Medical Devices Data Protection, (Cyber)security and AI Testimonial

We have trained the entire regulatory team of a medical device company on understanding GDPR compliance in a clinical research setting.

Healthcare Medical Devices Pharmaceuticals Data Protection, (Cyber)security and AI Testimonial

What distinguishes our lawyers is the ability to see the whole regulatory picture. We have assisted multiple clients, ranging from CROs to pharma start-ups to medical device manufacturers, in setting up GDPR compliance processes and agreements that allow for seamless interaction with other legal frameworks such as MDR and IVDR.

Digital Health Medical Devices Data Protection, (Cyber)security and AI Testimonial

We have assisted a medical device manufacturer in ensuring that their SAAS-application complies with the Data Act and the GDPR.

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