Selecting a Notified Body and Preparing for the MDR Audit

This is not a procurement decision

Choosing a Notified Body feels like it should be a straightforward comparison exercise — scope, price, timelines, reputation. In practice it is more constrained than that. The NB you can work with is determined first by their designation: if their designation does not cover your device codes, the rest of the comparison is irrelevant. And the NB you should work with depends on factors that are not always visible from the outside: their current audit backlog, their approach to borderline technical questions, and whether they have auditors with relevant domain experience for your device type. Getting this right saves time. Getting it wrong means you find out 18 months in that something fundamental needs to change.

The first filter is always designation scope. The European Commission's NANDO database lists every designated NB, their notified scope by regulation, and the specific device codes (MDN codes) they are designated to cover. Before any other consideration, check that the NB you are considering is designated for MDR 2017/745 and that their designation scope includes your device classification and type. Not all NBs are designated for all device types — some are strong in active implantables, some in IVDs (which are a separate regulation), some in software and SaMD. The gap between "this NB is well-known" and "this NB can certify my device" is real and worth checking early.

The second filter is capacity and timeline. Since MDR application in 2021, designated NB capacity has been under significant pressure. Wait times for initial audit slots have ranged from several months to over a year at the most in-demand bodies. Some NBs publish indicative timelines for initial applications; many do not. Direct contact — sending an application for quotation and timeline estimate — is usually the only way to get a real number. One practical tip: apply to more than one NB in parallel, at least at the initial enquiry stage. The cost of an enquiry is low; the cost of having committed to one NB and finding out their next available slot is 14 months away is not.

Once you have selected a NB, the preparation work begins well before the audit date. Under an Annex IX route, the NB will audit both your QMS and your technical documentation. MDR Annex IX is more demanding than the equivalent MDD annex in several ways that matter for preparation:

• Clinical and PMS evidence at QMS level: Under MDR, the NB's QMS audit includes review of how you manage clinical evaluation, post-market surveillance, and the feedback loop between the two. This is not limited to a check of your procedures — auditors will look at the actual outputs: your CER, your PMS plan, your PSUR or PMSR. Having these documents complete and current before the audit is not optional.

• Complaint handling and vigilance: The NB will assess whether your complaint and vigilance processes meet MDR requirements, including the new serious incident reporting timelines and the trend reporting obligation. Teams that carried over their MDD-era complaint procedures without MDR-specific review often find gaps here.

• Supplier and outsourcing controls: MDR places greater emphasis on control of critical suppliers and outsourced processes. The NB will look at how you qualify suppliers of critical components and services, what your supplier monitoring process looks like, and whether your technical documentation reflects the actual supply chain.

The technical documentation review — whether as part of Annex IX or as a standalone type examination — will focus on design verification and validation evidence, risk management, and clinical evidence. The most common NB finding in technical documentation review is not missing documents but documents that are present but not linked: a risk analysis that does not connect to the verification testing results, a clinical evaluation that does not address the residual risks identified in risk management. Reviewers are looking for a coherent story, not a document checklist.

If you are transitioning from MDD certificates, your existing NB has first right of refusal for the MDR audit. This means you should discuss your transition timeline with them early — but it does not mean you are obligated to stay with them if their capacity, designation scope for your MDR device classification, or audit approach is not the right fit. Manufacturers who held MDD Annex II certificates (full QMS) tend to have a smoother transition because the audit infrastructure is already in place. Those who held Annex V or VI certificates (product-level only) may need more preparation time to build the QMS foundations that MDR requires even for Class IIa devices.