EU MDR Notified Body Route Selection

Classify the device under Article 51 and Annex VIII before choosing a notified body path. The MDR divides devices into classes I, IIa, IIb, and III by intended purpose and inherent risks; that classification drives the Article 52 conformity assessment procedure.

For class III devices, Article 52 points to Annex IX, or Annex X coupled with Annex XI. For class IIb devices, Article 52 points to Annex IX with technical documentation assessment for representative devices per generic device group; class IIb implantable devices generally require assessment of every device, except the exempted sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. For class IIa devices, Article 52 points to Annex IX with representative technical documentation assessment per category, or Annexes II and III coupled with an Annex XI route. For class I devices, the manufacturer normally declares conformity after drawing up Annexes II and III technical documentation, but notified body involvement is triggered for sterile devices, measuring devices, and reusable surgical instruments, limited to the relevant sterile, metrological, or reuse aspects.

Do not treat a legacy certificate, distributor request, or preferred notified body relationship as the route decision. The route decision should show the class, the Article 52 paragraph, the chosen Annex path, any special procedure, and the reason a notified body is or is not involved.

A notified body is required when the applicable conformity assessment procedure calls for third-party intervention. Article 52 makes that involvement compulsory for class IIa, IIb, and III devices, and limited but still required for class I devices placed on the market sterile, with a measuring function, or as reusable surgical instruments.

When notified body involvement is required, Article 53 allows the manufacturer to apply to a notified body of its choice only if that notified body is designated for conformity assessment activities related to the device type. The route memo should therefore pair the Article 52 route with evidence that the selected notified body can assess the product, not only that the body has a valid notified body number.

Avoid relying on voluntary or unregulated certificates as route evidence. NANDO warns that certificates issued outside a notified body's notified area do not prove compliance with EU harmonisation legislation.

The notified body selection step should verify both legislation and scope. The Commission's notified body page explains that designated notified bodies are published in NANDO and can be filtered by legislation for Regulation (EU) 2017/745. The NANDO legislation search is the public route for finding bodies notified to carry out conformity assessments for a selected legislation.

Check the designation codes as well as the notified body's name. MDCG 2019-14 explains that designating authorities use MDR codes to define a notified body's designation scope and that notified bodies use them to describe staff qualifications and allocate conformity assessment teams. Manufacturer-side route evidence should therefore include the device's MDA or MDN code, applicable MDS and MDT codes, and the rationale for any difficult code choices.

MDA and MDN codes describe the device design and intended purpose; MDS codes identify specific characteristics such as sterility or medicinal substances; MDT codes describe production technologies and processes. MDCG 2019-14 recommends one MDA or MDN code per device, normally the highest applicable entry in the list, all applicable MDS codes, and the MDT codes describing the main production processes. Record the device fact behind each code and any exceptional selection rationale. The notified body verifies the proposed codes at application review and makes the final assignment.

If the notified body cannot confirm that the device and technologies fit its designation and resources, treat that as a route blocker before submitting a full application package.

Route selection is only useful if the application package can survive notified body review. Article 10 requires manufacturers to keep technical documentation up to date, draw up the EU declaration of conformity after the applicable conformity assessment, keep relevant certificates available where applicable, and establish a quality management system proportionate to the device risk class and type.

For notified body routes, prepare the QMS evidence, Annexes II and III technical documentation, risk management file, clinical evaluation report, PMCF or PMS plans where applicable, standards or common specifications rationale, labeling and instructions for use, supplier and critical subcontractor records, and change-control history before application review.

Clinical evidence readiness matters because MDR defines clinical evidence as clinical data and clinical evaluation results of sufficient amount and quality to allow a qualified assessment of safety and clinical benefit. Annex XIV requires clinical evaluation results and supporting clinical evidence to be documented in a clinical evaluation report and included in technical documentation.

Keep a compact route-selection record that a reviewer can follow without reconstructing the product history. The record should prove the class, route, notified body scope check, application state, readiness package, certificate state, and unresolved blockers.

For issued certificates, retain the certificate type and the Annex XII content applicable to that type. Technical documentation assessment, type-examination, and product verification certificates identify the device, intended purpose, risk class, and Basic UDI-DI. QMS and quality assurance certificates identify devices or device groups and class, with intended purpose required for class IIb. Keep conditions of validity, supplements, amendments, surveillance reports, and links to the EU declaration of conformity and technical documentation. For refused, withdrawn, or transferred applications, retain the notified body correspondence and the Article 53 declaration history.

Reopen the route decision after intended-purpose changes, design changes, sterilization or measuring changes, software changes, supplier or critical subcontractor changes, standards or common specifications changes, clinical evidence changes, certificate restrictions, notified body scope changes, or authority feedback.