We support medical device and IVD manufacturers through the procedure with the notified body, from selection to the renewal of the certificate. The MDR and IVDR bar the notified body from advising on design, manufacture, marketing or maintenance of the devices it assesses.
Overview
Notified body procedure for medical devices and IVD · MDR Art. 53, 56 and 58, IVDR Art. 49, 51 and 53 · Annex VII of the MDR and IVDR · MDCG 2019-6 Rev. 5
Last updated: October 29, 2026
The notified body assesses and decides; it may not advise (Annex VII Section 1.2.3 of the MDR and IVDR). Much of what holds a procedure up is therefore already written in the procedural rules of both regulations and in the MDCG guidance.
Industries
Services
Matching device, class and the chosen conformity assessment route against the scope of designation in NANDO, described with the codes of Implementing Regulation (EU) 2017/2185, together with the languages a notified body accepts for documentation and correspondence and its published standard fees. Deliverable: a reasoned shortlist with the open points for each notified body.
Putting quotations from several notified bodies on a common basis: which activities they cover (audit of the quality management system, assessment of the technical documentation per device or by sampling, surveillance, specific procedures), which assumptions sit behind them and what is missing. The manufacturer signs the contract directly with the notified body (Annex VII Section 4.2(e)); we prepare the decision.
Formal application with all information and declarations the relevant Annex IX, X or XI requires, including the information on withdrawn or refused earlier applications, and a review of the contract against the obligations in Annex VII Section 4.3. Deliverable: an application package checked against the criteria the notified body uses to review applications for completeness.
Preparing the meetings with the notified body before and after the application that MDCG 2022-14 and MDCG 2019-6 Rev. 5 recommend: questions on timelines, documentation, classification and sampling, phrased to ask what needs to be fulfilled. Deliverable: a list of questions and minutes of the answers.
Preparing the renewal: for EU technical documentation assessment certificates and EU type-examination certificates with the summary of changes and scientific findings under Annex VII Section 4.11, for quality management system certificates with the audit and surveillance results of the cycle (MDCG 2019-6 Rev. 5); for a change of notified body, the agreement under Art. 58 MDR or Art. 53 IVDR with the end of validity, the transfer of documents and the last serial or lot number of the outgoing notified body. Deliverable: a timeline up to the expiry of the certificate.
How we work together
Where a procedure requires a notified body, the MDR leaves the choice to the manufacturer, but only among notified bodies designated for the types of devices concerned (Art. 53(1)), and it excludes parallel applications for the same procedure. The IVDR sets out the same in Art. 49; the designations under both regulations are listed in NANDO.
How the notified body then works is set out in Annex VII of both regulations. Before a quotation it verifies whether the product is covered and how it is classified. It reviews the formal application for completeness, classification, the chosen procedure, its own designation and its resources; before the decision, no non-conformity may remain that would prevent a certificate.
The notified body may not give advice along the way. Annex VII Section 1.2.3 excludes consultancy on the design, construction, marketing and maintenance of the devices under assessment; Section 1.2.9 allows exchanges of technical information and regulatory guidance. The MDCG calls this exchange structured dialogue and recommends it before and after the application.
The Commission proposal for the targeted revision of the MDR and IVDR would introduce a legal basis for structured dialogue in Annex VII. This page describes the procedure under current law and current guidance; what becomes of the proposal is for Parliament and Council to decide.
| What the MDR and IVDR set out | What the manufacturer provides | |
|---|---|---|
| Before the quotation | preliminary verification of scope and classification; published description of the application procedure with the accepted languages (Annex VII Section 4.2) | device description, intended class and conformity assessment route |
| Application and contract | formal application under Annex IX, X or XI; written contract directly between manufacturer and notified body (Annex VII Sections 4.2 and 4.3) | application with information on withdrawn and refused applications (Art. 53(3) MDR, Art. 49(3) IVDR) |
| Assessment | depending on the procedure, audit of the quality management system, assessment of the technical documentation or type examination; the notified body may require further tests or evidence (Annex IX Section 4.3) | answers to questions, corrections and corrective actions for non-conformities |
| Decision | final review by personnel who did not conduct the assessment; no open non-conformity that would prevent a certificate (Annex VII Sections 4.7 and 4.8) | documented resolution of non-conformities |
| Validity | five years at most, extension on application after re-assessment (Art. 56(2) MDR, Art. 51(2) IVDR) | for product certificates, the summary of changes and findings (Annex VII Section 4.11); for quality management system certificates, the audit and surveillance results of the cycle (MDCG 2019-6 Rev. 5) |
A certificate is valid for five years at most. To renew a product certificate the manufacturer submits a summary of changes and findings, including changes not yet notified; for quality management system certificates the notified body relies on the audits and surveillance of the cycle. Changing notified body takes an agreement under Art. 58 MDR or Art. 53 IVDR that sets, among other things, when the old certificates become invalid.
Outside this page are the route to CE marking with the choice of conformity assessment procedure per class, preparation for notified body audits including unannounced audits, and notifying planned changes to a certified device.
Our approach
Step
Result
Select
A shortlist of notified bodies whose designation covers the device and the procedure, with quotations on a common basis.
Apply
A formal application and a signed contract, with questions on timelines and documentation settled beforehand in the structured dialogue.
Go through the assessment
Questions and non-conformities in a log, each with answer, evidence and date, until no non-conformity remains that would prevent the certificate.
Keep the certificate
A certificate with a known period of validity and its supplements, and a date for recertification, prepared with the summary of changes or the results of the surveillance cycle, depending on the certificate.
Common pitfalls
Quotations are compared by their total.
Where the notified body assesses the technical documentation of representative devices, its sampling plan has to cover the entire range of devices in the application over the validity of the certificate (Annex VII Section 4.5.2(a)): under the MDR for class IIa and IIb, with class IIb implantables outside the exemption list assessed device by device (Art. 52(4), second subparagraph), under the IVDR for class B and C, with companion diagnostics assessed device by device (Art. 48(7), third subparagraph) and Annex IX Section 5.1 added for self-testing and near-patient testing. A quotation that prices only the first sample cannot be compared with one that prices the plan.
Answers to questions change the technical documentation without the new version being traceable.
Before deciding, the notified body has to verify that the resolution of non-conformities is completely documented (Annex VII Section 4.7); an answer that does not point to the revised part of the documentation draws the next question.
Renewal is planned only when the certificate is about to expire.
It requires an application and a re-assessment (Art. 56(2) MDR, Art. 51(2) IVDR); for EU technical documentation assessment and EU type-examination certificates, the summary for it covers all changes to the originally approved device, expressly including changes not yet notified (Annex VII Section 4.11(a)).
After a change of notified body, the identification number of the outgoing notified body stays on labels and in promotional material.
The transfer agreement has to set the date until which it may appear in the manufacturer's information, and the last serial or lot number for which the outgoing notified body is responsible (Art. 58(1)(b) and (e) MDR, Art. 53(1) IVDR).
Regulatory Affairs
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
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Latest insights
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Technical Documentation & UDI →
The technical documentation under Annexes II and III that the notified body assesses
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The counterpart for medicinal products: scientific advice and communication with EMA and FDA
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
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