Unannounced Audits of Medical Device Critical Subcontractors and Crucial Suppliers

1 Hour and 30 Minute Video | Erik Vollebregt, Axon Lawyers

The EU recommendation on unannounced audits applies not only to medical device manufacturers, but also to device critical subcontractors and crucial suppliers who contribute to the main product design, development, and manufacture. The more significant this contribution is, the more likely it is that the manufacturer’s notified body will also audit the supplier or subcontractor.

The primary challenge for all device manufacturers is that a precise definition of what is and is not considered a critical subcontractor and crucial supplier is unclear at this time. Non-compliance on behalf of the supplier or subcontractor will result in major repercussions for a manufacturer because it will cause the notified body to suspend or revoke the CE certificate for the device(s) concerned. Therefore, adequate understanding of the regulation is necessary to ensure successful audits. In addition, manufacturers must accommodate for unannounced audits in their agreements with suppliers and subcontractors in order to ensure their cooperation with unannounced audits.

  • Criteria for determining if a subcontractor/supplier is significant
  • Manufacturer responsibilities specific to suppliers/subcontractors
  • Key considerations in agreements with suppliers/subcontractors
  • How to ensure that the subcontractor / supplier completes an unannounced audit successfully


Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Quality Assurance
  • Supplier Quality
  • Legal Counsel
  • Audits

This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.


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Erik Vollebregt
Lawyer and Founding Partner
Axon Lawyers

Erik is a lawyer who specialized in EU legal issues relating to medical devices. He has wide experience in life sciences legislation and regulatory, at EU and Dutch level. Erik was trained as intellectual property and competition lawyer. He has gained experience in contentious matters, commercial contracts, and transactional work at the Directorate-General for Competition of the European Commission. He also worked for three large international law firms.

Erik is a prolific writer and publishes in life sciences legal and regulatory journals on a wide variety of subjects. He is an editor of the Dutch life sciences law and regulatory journals Jurisprudentie Geneesmiddelenrecht and JGR Plus, as well as and author of a Dutch handbook on misleading and comparative advertising law Oneerlijke handelspraktijken, misleidende reclame en vergelijkende reclame. Additionally, he has a weblog on legal and regulatory aspects of medical technology, Medicaldeviceslegal. Erik is further authoring several medical technology chapters of RAPS’ EU Fundamentals of Regulatory Affairs. He often lectures at (inter)national conferences and is a guest lecturer on pharmaceutical law, medical technology law and advertising law at the universities of Groningen and Twente.

As additional external activity Erik is president of the NEN (Dutch Standardisation Institute) Platform on Software and Medical Devices. His memberships include the Netherlands Biotech Industry Association (NIABA), the Dutch Association Pharmacy and Law (VFenR), the Dutch Association for Healthcare Law (Vereniging voor Gezondheidsrecht), the Dutch Association for Advertising Law (VvRr), and Regulatory Affairs Professional Society (RAPS)

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