Tech Talk

Preparing for Unannounced Inspections From Notified Bodies for Medical Devices

Europe has introduced further measures for unannounced audits of manufacturers by notified bodies. With this in mind, James Pink, VP Europe-Health Sciences Medical Devices at NSF International, provides a little help to prepare for them.

Background

There are two important documents that are concerned with unannounced inspections:

- European Commission (EC) recommendation of September 24, 2025 concerning unannounced audits by notified bodies in the field of medical devices

- Team NB’s Code of Conduct for Notified Bodies version 3.0 October 2012, Pages 21-23

Unannounced inspections are already being undertaken by notified bodies and competent authorities are preparing for them to become mainstream by early 2014.

Consider the following steps to ensure that you are prepared for EU notified body unannounced inspections.

1. Be prepared: Establish and review the sources of information for unannounced inspections; in particular, ensure you create links with other companies in the area with the same notified body and products. Review your contract with your notified body and ensure you identify when you are manufacturing product. Communicate this through your organization and to your notified body.
2. Plan for unannounced audits: Undertake formal business continuity planning activities to ensure you consider worst-case scenarios and develop procedures that can be used later for drills, exercises and simulations. These procedures can then serve as the basis of your business continuity strategy.
3. Undertake your own mock unannounced audits: There is nothing better than actually undertaking mock audits. Utilize NSF Health Sciences’ expert audit team to help kick off unannounced inspections so you can learn lessons from the best in the business and refine your contingency procedures.
4. Implement procedures for unannounced inspections: It is imperative that you have procedures that inform and train all personnel involved in unannounced inspections so that they can implement them as soon as an unannounced inspection occurs. Do not forget that this also needs to extend to your supply chain!
5. Raise awareness and train your people and suppliers for managing inspections: Practice makes perfect. Simulation, exercises, drills, scenarios − whatever you
   call them, there is nothing better than training your people and suppliers so that you can use assessment methods to understand whether they are able to contingency plan, apply unannounced audit procedures and, more importantly, effectively respond to notified body requests during the audit. Do not underestimate the importance of having competent and confident people on hand during the audit.
6. Maintain compliance to the EU medical device directives: Implement procedures for unannounced inspections: Are your devices classified correctly? Do your declarations of conformity actually cover every medical device? Is your technical file updated with the appropriate information so that it shows you are on top of things?

If not, you need to ensure that you have a technical file review, a risk management review and post-market surveillance summaries that are current and responding to your data.

Consider the scenario of a notified body suspecting that your device is not in accordance with the medical device directive’s essential requirements – How do you prove it is, do you have the evidence and do you have access to the relevant tests and information?

7. Use the NSF Health Sciences Medical Devices team for support: Whether regulatory strategy, regulatory science, quality assurance, training, auditing or testing, we can help you. We are only a phone call away.

Each of these steps is addressed in more detail in the downloadable PDF attached