Article 58 of Regulation (EU) 2017/745 lets manufacturers voluntarily change their Notified Body, but only under strict conditions: a written agreement between the outgoing and incoming Notified Bodies, a clear handover of the technical documentation and surveillance history, and defined arrangements for certificate validity during the transition. Done well, the changeover happens with no gap in certification. Done badly, it creates a legal hole that can suspend your right to place devices on the market.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • MDR Article 58 governs the voluntary change of Notified Body by the manufacturer.
  • The outgoing and incoming Notified Bodies must conclude an agreement that clearly defines the date of withdrawal of the old certificates, the date of issue of the new ones, and the responsibilities for ongoing surveillance.
  • Article 58(1) requires the manufacturer to inform the outgoing Notified Body of the termination of the agreement.
  • Continuity of certification depends on the timing of the agreement between Notified Bodies — a gap between the old certificate ceasing to apply and the new one being issued means the device cannot be lawfully placed on the market during that gap.
  • Plan the changeover 9 to 18 months before the old certificate expiry, because Notified Body capacity remains tight and a rushed switch often results in capacity rejection.

Why a startup would even consider switching

The stereotype is that once you are certified by a Notified Body, you stay with them forever. In practice, the reasons startups switch are straightforward and almost always commercial or operational.

Capacity. A Notified Body that accepted the manufacturer when it was small may no longer prioritise a small account when its queue fills with larger clients. Audits slip. Questions take weeks to answer. Certificate amendments stall. At some point the founder decides the cost of staying exceeds the cost of switching.

Fit. Some Notified Bodies are stronger in certain device categories than others. A startup whose product evolves from a simple Class IIa sensor into a complex Class IIb software-driven device may find its original Notified Body lacks the reviewers with the right software background. The audit starts feeling like an education exercise.

Fees. Pricing varies widely, especially as Notified Bodies reprice MDR designations. A doubling of the annual surveillance fee is not rare, and for a bootstrapped company it is enough to trigger the question of whether another designated body would be cheaper or at least more predictable.

Service. Some Notified Bodies answer technical questions in 48 hours; others take six weeks. For a startup iterating on a device, the difference is material.

None of these reasons are a criticism of the outgoing Notified Body. Both bodies are designated under MDR Article 46 and authorised to perform conformity assessment. The manufacturer has a right to switch. Article 58 is the mechanism.

What MDR actually says about the change of Notified Body

Article 58 is titled "Voluntary change of notified body". It establishes a controlled procedure rather than a free-for-all. The essential elements, verified against the consolidated text, are:

  • The manufacturer and the new Notified Body conclude a contract for conformity assessment.
  • The manufacturer informs the outgoing Notified Body of the termination of its agreement.
  • The outgoing and incoming Notified Bodies conclude an agreement that specifies, at minimum, the date on which the certificates issued by the outgoing Notified Body cease to be valid and the date on which the certificates of the incoming Notified Body take effect.
  • The outgoing Notified Body transfers the relevant documentation, including the technical documentation it reviewed and the surveillance history of the manufacturer, to the incoming Notified Body.
  • The outgoing Notified Body remains responsible for its past conformity assessment activities until the handover is complete.

Article 56 addresses certificates of conformity and their validity more generally, including what happens when a certificate is suspended, restricted, or withdrawn. Article 58 is designed to ensure that a voluntary change does not trigger the consequences of Article 56 if the handover is done properly.

Article 46 sets out the designation process for Notified Bodies. Both the outgoing and the incoming must be designated for the relevant scope under MDR, or the change cannot be completed.

The critical concept in Article 58 is the agreement between the two Notified Bodies. It is not optional, and it is not a formality. Without that agreement, the manufacturer is technically between two certificates, and during that interval placing new units on the market is not lawful under Article 5.

A worked example: a Class IIb software device changeover

A startup holds an MDR Annex IX certificate for a Class IIb software-driven device, issued in June 2023 by Notified Body A, valid for five years. By late 2025, the manufacturer decides Notified Body B is a better fit because of stronger software expertise. The certificate expires in June 2028, so the startup has time — but not unlimited time.

Month 0 (January 2026). The startup contacts Notified Body B for a quotation and capacity confirmation. Notified Body B indicates it can accept the file but the initial review will take 6 to 9 months from contract signature.

Month 2 (March 2026). The startup signs the contract with Notified Body B and formally informs Notified Body A under Article 58(1) that it intends to terminate the existing agreement.

Month 3. Notified Body A and Notified Body B begin discussing the handover agreement. This is the step startups forget about. The two Notified Bodies — commercial competitors — must agree in writing on dates, scope, and document transfer. In practice this takes weeks of correspondence.

Months 4 to 10. Notified Body B reviews the full technical documentation transferred from A, plus the QMS surveillance history. A re-audit of the QMS against EN ISO 13485:2016+A11:2021 and MDR Annex IX may be required depending on the incoming body's policies.

Month 11 (December 2026). The written agreement between A and B is finalised. It specifies that the certificates issued by A cease to be valid on 15 January 2027 and that the certificates issued by B take effect on 15 January 2027 — the same day. No gap.

Month 12. Notified Body B issues the new certificates. The manufacturer updates the Declaration of Conformity, the technical documentation cover page, and Eudamed references. Business continues uninterrupted.

The reason this works is that every party planned backwards from the need for certificate continuity. If the startup had waited until month 18 to start, the agreement between bodies would not have been finalised in time, the old certificate would have lapsed or been withdrawn, and every unit produced during the gap would have been unlawfully placed on the market.

The Subtract to Ship playbook

1. Decide whether to switch on evidence, not emotion. Document the specific problems with the current Notified Body and compare them against the cost of switching — typically six to twelve months of your senior team's attention and a fresh technical documentation review fee. Switching for fit and capacity is rational. Switching because one email took too long is not.

2. Start at least 12 months before the old certificate expires. Article 58 does not specify a minimum lead time, but the market does. Notified Body capacity is tight and the handover agreement between bodies is not a weekend job.

3. Do the capacity conversation with the incoming body first. Before you write to the outgoing body, confirm the incoming body can actually take you. A rejected incoming application after you have already informed the outgoing body leaves you with a burned bridge and no plan.

4. Get the handover agreement in writing and read it. It is not the Notified Bodies' problem if the dates in the agreement do not line up. It is yours. Read the agreement, confirm the certificate cessation date and the certificate issue date match, and keep a copy in your QMS records.

5. Keep the outgoing body properly paid and in good standing until the handover is complete. Article 58 makes the outgoing body responsible for past conformity assessment activities until transfer is complete. A hostile exit creates risks you do not want.

6. Re-verify your scope. Make sure the incoming Notified Body's designation covers every device code and every conformity assessment route in your portfolio. A switch that covers four out of five device families is not a switch, it is a problem.

7. Plan the Declaration of Conformity and Eudamed updates. On the day the new certificate takes effect, your Declaration of Conformity references change. Update the master document, the labels if they reference certificates, and Eudamed certificate records.

Reality Check

  1. Have you written down the specific reasons for wanting to switch Notified Bodies, and are they material?
  2. Have you confirmed that at least one alternative Notified Body is designated for your full device scope under MDR Article 46?
  3. Have you had a capacity conversation with the incoming body and received a realistic timeline?
  4. Do you have at least 12 months before your current certificate expires?
  5. Do you understand that the outgoing and incoming Notified Bodies must conclude a written agreement under Article 58 specifying the certificate cessation and issue dates?
  6. Have you mapped which internal documents — Declaration of Conformity, labels, Eudamed references — need updating on the day of the switch?
  7. Can you produce, from your QMS, the complete surveillance history the outgoing body will transfer?

Frequently Asked Questions

Can a manufacturer switch Notified Bodies at any time? Yes, Article 58 gives manufacturers the right to voluntarily change Notified Body. But the change only takes legal effect once the contractual and handover steps in Article 58 are complete, including the agreement between the outgoing and incoming Notified Bodies.

Does switching require re-certification from scratch? Not always. The incoming Notified Body reviews the transferred technical documentation and surveillance history and decides what additional work is needed. In practice, expect at least a gap analysis, possibly a full QMS audit, and targeted technical documentation review depending on device class.

Can there be a gap between the old and new certificates? Legally, no. Article 5 only allows placing on the market of devices that comply with the MDR, which for Class IIa and above means valid certification. A gap means you cannot lawfully place new units on the market during the gap, even if production continues.

Who pays for the changeover? The manufacturer. Both Notified Bodies charge for their respective work, and there is no cost sharing with anyone else.

Is the outgoing Notified Body obliged to cooperate? Article 58 requires the outgoing Notified Body to transfer the relevant documentation and cooperate on the handover agreement. A body that refused to cooperate would be failing its regulatory obligations, and the competent authority could intervene under Article 46.

Should a startup consider switching before its first certificate is issued? If you have signed a contract with a Notified Body but not yet received a certificate, Article 58 does not apply because you have no certificate to transfer. You can terminate the contract under its commercial terms and start fresh with another body. But you pay twice for the same assessment work, so the decision has to be based on strong evidence.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 5, 46, 56, 58.
  2. EN ISO 13485:2016+A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes.