A Notified Body is not a regulator. That single sentence clears up half of the confusion manufacturers bring into a kickoff meeting.

Under Regulation (EU) 2017/745 (MDR), a Notified Body is a conformity assessment body designated under Article 35 by a Member State, notified to the European Commission, and listed in the NANDO database with a four digit identification number and a specific scope. Scope is the part most manufacturers miss. Two Notified Bodies can both be designated under MDR and still cover entirely different device categories, sterilization technologies, or measuring function aspects. The brochure will not tell you that. The NANDO listing will.

How a body becomes notified

The route is laid out in Articles 35 to 50. The applicant body submits to its national designating authority, which runs a preliminary assessment. The Medical Device Coordination Group and the European Commission then run a joint assessment, sending a team of assessors from other Member States into the applicant body to review files, sit in on audits, and probe competence on the requested scope codes. Designation is granted scope by scope, and periodic reassessments follow.

This is why the answer to “can you certify our device under code MDA 0301” is sometimes “not yet, that code is still pending in our designation.” That is a real constraint on the body’s side, even when it sounds like a stall.

What an assessment actually involves

The MDR sets out several conformity assessment routes in Annexes IX, X, and XI. Most manufacturers will be on Annex IX, which combines a quality management system audit with a technical documentation assessment.

The QMS audit looks at how you actually operate. Design controls, risk management aligned with ISO 14971, supplier controls, CAPA, post market surveillance and vigilance against the requirements of Articles 83 to 92, and the linkage between your PMS data and your clinical evaluation under Annex XIV. The auditors are not there to test whether you have written procedures. Almost everyone has written procedures. They are there to test whether the procedures match what people on the floor and in the design office are doing.

The technical documentation assessment is a separate workstream under Annex II for the technical documentation itself and Annex III for the post market documentation. For Class III and certain Class IIb implantables, every TD goes through this review. For other Class IIb and Class IIa devices, the Notified Body samples per the rules in Annex IX. The reviewer asks whether the device complies with the General Safety and Performance Requirements in Annex I, whether the clinical evaluation under Annex XIV supports the claims, and whether the labeling and instructions for use match the evidence.

If the evidence does not support the claim, either the claim has to change or the evidence has to. Manufacturers sometimes try to argue a third option, which is that the reviewer should accept the claim anyway. That has not worked in any submission I have seen.

The deficiency cycle is the actual work

Most of the visible work on a TD review is the deficiency cycle. The reviewer issues findings, the manufacturer responds, the reviewer assesses the response, and either closes the finding or issues a follow up. Each round adds calendar time. Submissions with thin clinical evidence or vague risk benefit analyses often go through three or four rounds. Submissions where the design rationale is well documented and the GSPR checklist genuinely traces to evidence usually close in one or two.

The fastest TDs I have seen through review were not the simplest devices. They were the ones where the manufacturer had clearly anticipated the reviewer’s questions.

Surveillance does not end at certification

A certificate is a snapshot of compliance at the moment it was issued. From the day it is signed, the Notified Body is responsible for ongoing surveillance under Article 56 of the MDR. That includes annual surveillance audits, periodic reassessments of the technical documentation, vigilance signals from EUDAMED and from the body’s own files, and unannounced audits as set out in Commission Implementing Regulation (EU) 920/2013.

Unannounced audits are the part manufacturers underestimate. The audit team can show up at the legal manufacturer, at critical subcontractors, or at crucial suppliers, and they can pull product, request test results, and witness production. If access is refused, the body can suspend or withdraw the certificate under Article 56.

Changes also have to flow back to the file. A change in intended purpose, design, materials, sterilization method, or production site is not something the manufacturer decides has been “minor.” Annex IX and Annex VII set out how substantial changes have to be notified to the Notified Body and approved before they are implemented. Putting a substantially changed device on the market under an old certificate is one of the most common, and most expensive, mistakes in the system.

Why a Notified Body cannot consult

This is the one that frustrates manufacturers the most. The independence and impartiality requirements in Annex VII prohibit a Notified Body from offering consultancy services to its clients on how to comply, how to design the device, or how to write the technical file. The same applies to its personnel, its parent organization, and any subsidiary.

In practice this means an auditor can tell you that the evidence does not support a claim. The auditor cannot tell you what evidence to generate. That is not a customer service failure. It is a firewall that keeps the body from ending up certifying its own work. If you need someone to help you build the file, you hire a consultancy. The Notified Body assesses what you submit.

Where most submissions get stuck

Most of the delays I see come down to a few things, all of them visible before the file ever leaves the manufacturer’s desk.

The NANDO scope of the chosen Notified Body has to actually cover your device class, code, and any special characteristics such as sterile, measuring function, or use of materials of animal origin. A misaligned scope gets the file rejected at intake, not certified late.

The trace between Annex I, Annex II, and Annex XIV is the other recurring issue. The General Safety and Performance Requirements are the standard. The technical documentation is the proof. The clinical evaluation is the bridge between the claims and the evidence. When those do not visibly connect, the technical documentation spends its life in the deficiency cycle.

And then there is the post market loop, which manufacturers most often treat as something to handle after certification. PMS, PSUR, PMCF, and vigilance under Articles 83 to 92 are not homework that begins after the certificate is issued. They are conditions of the certificate, and Notified Bodies pay attention to how seriously a manufacturer takes them well before the first surveillance audit.

A Notified Body is the independent check between the manufacturer and the market. The submissions that move through fastest are the ones that look, from the outside, like they were already written for the reviewer.