Does Your Medical Device Need a Notified Body Under EU MDR? A Practical Guide

Confirm the device and intended purpose first

A notified body is an organisation designated to perform specified conformity assessment tasks. It is not the manufacturer, a general testing laboratory or a registration database. This guide helps manufacturers and purchasing teams screen ordinary MDR routes; it does not classify an unidentified product.

Ask the manufacturer for the intended purpose, model and configuration, intended users, patient group, contact with the body, duration of use, sterile status and relevant software or accessories. Obtain a written classification rationale naming the Annex VIII rule and any applicable exceptions. Classification follows the intended purpose and device characteristics. Where several rules apply, the rule producing the highest class governs; a similar-looking product is not a sufficient precedent.

Use the table only after confirming that the product falls under MDR. In vitro diagnostic devices follow IVDR. Custom-made devices, health-institution manufacture, investigations and specific derogations need a separate route review rather than an automatic answer from this table.

A quick decision table for ordinary MDR devices

Article 52 connects the device class to its assessment procedure. Is, Im and Ir are useful Class I category labels, not three additional risk classes. A device can have more than one of those features. Confirm every relevant aspect rather than stopping at the first label.

Check the three Class I triggers carefully

• Supplied sterile. Check the manufacturer’s supplied condition, packaging and labeling. Being capable of sterilisation is different from being placed on the market sterile. The limited assessment concerns the sterility aspects; it does not transfer responsibility for the rest of the device to the notified body.
• Measuring function. Ask which measurement the device is intended to make and why the Class Im criteria apply. A printed scale or a number on a display is not a classification rationale. An electronic diagnostic device can belong to a higher class rather than Class Im; check the applicable rule before using this category.
• Reusable surgical instrument. Check the intended surgical use, whether it connects to an active device and the manufacturer’s intended reuse. A reusable product is not automatically a reusable surgical instrument. For Class Ir, assessment concerns reuse, including cleaning, disinfection, sterilisation, maintenance, functional testing and the related instructions.

Class I manufacturers still need conformity evidence

For ordinary Class I devices outside those three categories, the manufacturer completes the applicable conformity assessment and issues the EU declaration of conformity. Technical documentation, safety and performance evidence, clinical evaluation, risk management, quality management and post-market duties still matter. ‘Self-declared’ describes the route; it is not permission to omit evidence.

For a purchasing review, request the signed declaration, current labeling and instructions where required, plus an explanation connecting the actual model to the classification. Ask focused questions about gaps. Do not demand a notified-body certificate solely because the product is a medical device, or accept an unsupported Class I label to close the review.

If a notified body is needed, check its scope

Open the European Commission’s notified-bodies page and follow the MDR list in NANDO. Find the organisation by name or identification number. Verify designation under Regulation (EU) 2017/745 and the relevant device and procedure scope. An IVDR designation or an older Directive designation does not establish the scope needed for a new MDR assessment.

Manufacturers should confirm that the body can assess the proposed device and route before applying. Buyers should request the issued certificate with relevant schedules and amendments, then match its legal manufacturer and scope to the offered product. If the scope uses a device group, ask for a documented model mapping. Use independently obtained issuer contact details to resolve authenticity or coverage questions. An application, quotation or ISO 13485 certificate alone does not establish completed MDR certification.

Do not confuse an exception to a particular assessment step with an exemption from notified-body involvement. Regulation (EU) 2026/1359 expanded the list of Class IIb implantable devices exempted from technical-documentation assessment of every device under Article 52(4). It did not make those products ordinary Class I devices or remove the Class IIb conformity assessment route.

Two purchasing examples: ask what changed

These are hypothetical review scenarios, not classifications of actual products. In the first, a manufacturer provides a supported ordinary Class I classification for a non-sterile device with no measuring function and no reusable surgical-instrument status. The missing notified-body certificate is not itself a defect. Review the declaration and model evidence instead.

Now the supplier offers a sterile version of that device. Do not carry the earlier document conclusion across automatically: ask how the supplied condition and assessment route changed, and request the evidence for the sterility-related assessment. A sales description saying ‘sterilisable’ would require a different factual check from a label claiming sterile supply.

In the second, a seller describes a reusable surgical forceps as Class I and says no third party is needed. Ask whether it meets the MDR reusable surgical-instrument definition and whether any other rule changes the class. If it is properly Class Ir, the reuse-related assessment requires a notified body. Compare the assessment scope and reprocessing instructions with the exact instrument; do not assume every reusable accessory follows the same route.

Separate legacy and custom-made routes

A qualifying legacy device may still follow conditional MDD/AIMDD transition arrangements, including some devices needing a notified body for the first time under MDR. Absence of an MDR certificate alone therefore does not resolve its current supply status. Ask for the specific Article 120 basis, applicable end date and evidence that the conditions and application/agreement milestones were met. A transition is not a permanent exemption.

Custom-made devices use the Annex XIII procedure rather than the ordinary table. Class III implantable custom-made devices require notified-body assessment of the quality management system. The conditional derogation allowing placement on the market without that certificate ended on 26 May 2026. For an October 2026 supply review, check the current certification basis instead of relying on that expired route. Also distinguish genuinely custom-made devices from mass-produced products adapted for a patient.

Keep one clear route decision per device

Record the model and intended purpose, classification rule and rationale, sterile/measuring/reuse features, selected assessment procedure, notified body and scope where relevant, documents reviewed, open questions and review date. Assign an owner to each gap and revisit the decision when the product or claims change. Once the route is clear, use the companion supplier-verification guide in Related reading to check the documents and product match.

Review your MDR conformity route with Regunow

Use Regunow to research the applicable MDR provisions, compare classification evidence and examine supplier documents. Bring the intended purpose, proposed class and unresolved route questions together for your regulatory team’s review.