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Diagnostics

In vitro diagnostics are a species of medical devices that sit in a regulatory space of their own. Since the In Vitro Diagnostics Regulation took full effect, a far larger share of tests — including companion diagnostics, laboratory-developed tests and much in between — now demands notified body involvement, robust performance evidence and continuous post-market monitoring. Whether you are building a novel biomarker platform or adapting an established assay for clinical use, the underlying task is the same: turning scientific and analytical performance data into technical documentation that satisfies both the IVDR and the notified bodies reading it.

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Our expertise

We work closely with diagnostics manufacturers, clinical laboratories, pharmaceutical companies and hospitals across the full range of IVDR questions, from initial risk classification to the scientific validity and performance evidence that the IVDR requires. Working alongside regulatory affairs, legal, quality and laboratory teams, we translate complex scientific evidence into a regulatory and legal positions that are both compliant and defensible.

How we can help

We advise through the entire development and life cycle of a test or IVD. This typically involves answering complex borderline questions regarding the qualification of tests, establishing the correct risk class for your test and what it means for notified body involvement, then move to performance evaluation plans, scientific validity reports and the technical documentation itself. For laboratories developing and using their own tests, we advise on the precise conditions under which laboratory-developed tests may continue to be used under the IVDR. We help you put post-market performance follow-up and vigilance reporting in place. And when a notified body raises questions, a product has to be withdrawn or recalled, or a competent authority opens an inquiry, we are ready to act. We are equally experienced in assessing diagnostics-related regulatory risk in financing and M&A transactions. We draft and negotiate complex contracts in the (co-) development of companion diagnostic tests.

Our diagnostics 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

Cécile van der Heijden

Senior legal counsel and attorney-at-law

  • Regulatory
  • Litigation
  • Commercial

Stijn Gijsbers

Attorney-at-law

  • Regulatory
  • Commercial

Karin Verzijden

Partner and attorney-at-law

  • Regulatory
  • Commercial & IP
  • Litigation

Judith de Wilde

Attorney-at-law

  • Regulatory
  • Litigation

Max Baltussen

Attorney-at-law

  • Commercial & IP

Max Luijkx

Attorney-at-law

  • Corporate
  • Commercial

Inga Szweryn

Attorney-at-law

  • Corporate
  • Commercial
  • Regulatory

Maartje Hop

Attorney-at-law

  • Regulatory
  • Commercial & IP

Menno Knaven

Attorney-at-law

  • Corporate
  • Commercial

Jilles van der Hoek

Attorney-at-law

  • Regulatory
  • Litigation

Jasmin Buijs

External legal counsel

  • Regulatory

Recent

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Diagnostics Food and Feed Commercial Contracts Intellectual Property and Licensing Spin-out and Starter Advisory Testimonial

Axon assisted a start-up developing a real-time diagnostic test to define pathogens food. We negotiated and drafted an agreement with a university to support the further development & validation of the technology.

Diagnostics Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have advised manufacturers, distributors and authorised representatives on all aspects of the IVDR, including assisting a diagnostics manufacturer with the classification and conformity assessment of its in vitro diagnostic medical devices under the new IVDR framework.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have guided several clients through notified body interactions and discussions with competent authorities on product classification.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have supported an IVD manufacturer in the design and conduct of performance studies. We regularly advise clients on post-market performance follow-up (PMPF) obligations.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.

Diagnostics Regulatory Compliance and Enforcement Testimonial

Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.

Diagnostics Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.

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