A Notified Body is an independent, third-party organization designated by an EU member state to assess whether a medical device and its manufacturer’s quality system meet the requirements of the EU MDR or IVDR before the device can carry the CE mark and enter the European market.
What is a Notified Body?
A Notified Body sits outside the manufacturer’s organization and answers to a regulator, not to the client, which is what gives the CE mark its credibility. Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), a Notified Body is designated by an EU member state’s competent authority and listed in the European Commission’s NANDO database, which shows the device categories and procedures each body is authorized to assess.
Not every device needs one. Most Class I devices without a measuring function, sterile presentation, or reusable surgical component can self-declare conformity. Class IIa, IIb, and III devices, certain Class I variants, and most IVDs above Class A must go through a Notified Body before reaching the EU market.
Why Notified Body review matters in medical device development
For any manufacturer selling into the EU, the Notified Body stands between a finished device and market access. Without a valid CE certificate from a Notified Body, a Class IIa or higher device cannot legally be sold in the EU, no matter how complete its technical file is.
Since MDR replaced the old Medical Device Directive, the pool of designated Notified Bodies has shrunk and review capacity has tightened, so submission queues often run longer than legacy teams expect. A delayed or rejected review can force a redesign, trigger another round of verification and validation testing, or push a launch past a funding runway. Getting the technical documentation, risk file, and QMS evidence right before submission is one of the highest-value things a device team can do.
How the Notified Body conformity assessment process works
The exact route depends on device class and risk, but most assessments follow a similar arc:
- Quality management system audit: The Notified Body audits the QMS against ISO 13485, starting with certification, followed by annual surveillance audits and periodic recertification.
- Technical documentation review: For higher-risk devices, the Notified Body examines the technical file: intended use, design outputs, verification and validation data, the ISO 14971 risk file, biocompatibility, labeling, and clinical evaluation.
- Testing and sampling: For some categories, the Notified Body reviews test reports against standards like IEC 60601-1, IEC 62304, or IEC 62366-1, and may request data or samples.
- Certificate issuance: The Notified Body issues a CE certificate tied to specific annexes of the MDR or IVDR, referenced on the manufacturer’s declaration of conformity.
- Ongoing surveillance: Certificates run up to five years, with scheduled and occasional unannounced audits confirming the QMS and technical file stay current.
There is no central EU submission portal comparable to FDA’s eSTAR system. Manufacturers contract a Notified Body directly, chosen by its scope of designation, sector experience, and available capacity.
Common challenges and best practices
The most common failure point is a technical file written like an internal engineering record rather than a document meant for an external reviewer. Missing traceability between user needs, design outputs, and verification results is a frequent source of Notified Body findings.
Teams also underestimate lead time. Booking a slot, preparing for the QMS audit, and answering rounds of review questions can take many months from submission to certificate. Building that timeline into the product roadmap, instead of treating Notified Body review as a late formality, avoids a lot of scrambling.
Good practice: engage a Notified Body early to confirm classification and scope, keep the risk file and technical documentation as living records rather than assembling them retroactively, and run an internal mock audit against ISO 13485 first. Manufacturers who treat post-market surveillance and vigilance reporting as an ongoing input to the relationship, rather than closeout paperwork, tend to move faster through later audits.
How SJML helps with Notified Body readiness
What SJML’s compliance-as-a-service team does is prepare manufacturers to go into that review in strong shape: device classification and regulatory strategy, building and maintaining the technical file and DHF, structuring the risk management file to ISO 14971, and supporting the ISO 13485 quality system a Notified Body will audit. SJML also supports EU MDR and IVDR registration activity, clinical evaluation documentation, and the post-market surveillance and vigilance processes Notified Bodies expect to see maintained between audits. For manufacturers facing a first EU submission, or a legacy MDD-to-MDR transition, that groundwork often determines how smoothly the review goes.
Frequently asked questions
No. Most Class I devices without a measuring function, sterile presentation, or reusable surgical component can self-certify under EU MDR without third-party review. Class IIa, IIb, and III devices, certain Class I variants, and most IVDs above Class A require a Notified Body to review the technical documentation and quality system before the manufacturer can apply the CE mark.
A Notified Body is a private, independent organization designated by an EU member state to assess conformity under EU MDR or IVDR. The FDA is a US government agency that reviews submissions itself through pathways such as 510(k) or PMA. There is no EU equivalent to FDA review, and no US equivalent to Notified Body designation.
Timelines vary by device class, Notified Body capacity, and how complete the initial submission is. Since MDR took effect, review queues have generally lengthened compared to the legacy MDD era. Manufacturers should expect the process, from booking an audit slot to certificate issuance, to take many months, and should build that lead time into launch planning.
Yes, but it is disruptive. A new Notified Body typically restarts much of the technical review and QMS audit rather than accepting the prior body’s findings, since it is independently accountable for the certificate it issues. Manufacturers usually only switch when their current body’s designation does not cover their device category or capacity constraints make timelines unworkable.
The European Commission’s NANDO database lists every currently designated Notified Body along with the specific regulations, device categories, and technologies each one is authorized to assess. Checking a Notified Body’s scope of designation in NANDO before engaging them confirms they are actually authorized to review that manufacturer’s device type.
Related terms
- CE Marking
- EU MDR (Medical Device Regulation)
- Technical Documentation / DHF
- ISO 13485
- Post-Market Surveillance (PMS)
