Two Separate Exemptions
Secondary commentary often lumps "custom-made" and "in-house" together as one category of exempt devices. MDCG 2023-1, the Medical Device Coordination Group's guidance on the in-house exemption, says they are not the same thing: custom-made devices are out of scope of Article 5(5) and should follow the relevant requirements of the MDR. The two sit on different legal bases, with different consequences for EUDAMED.
A custom-made device is made to a written prescription from a person authorised by national law, with design characteristics set under that person's responsibility, for the sole use of one particular patient. MDCG 2021-3 breaks the definition in Article 2(3) of the MDR into three parts: a device that "is specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications", which gives "specific design characteristics provided under that person's responsibility", and "is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs." A custom-made device is still placed on the market. It just follows the conformity route in Annex XIII of the MDR instead of the standard one.
An in-house device is made and used only inside the same health institution, under Article 5(5) of the MDR and IVDR. It is not transferred to another legal entity, so it is never placed on the market. That is why its exemption is broader: EUDAMED's actor and device registration duties are both triggered by placing a device on the market. This guide covers the custom-made carve-out first, then the in-house exemption in its own section.
The Actor Registration Carve-Out
MDR Article 31 requires manufacturers, authorised representatives and importers to register as actors in EUDAMED before placing a device on the market, with one exception written into the article itself: "Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article." A manufacturer that places only custom-made devices on the market does not have to register as an actor before doing so.
MDCG 2021-13 rev.1, the MDCG's Q&A on actor registration, puts it plainly: "manufacturers of only custom-made devices are exempted from the obligation of registering as actors in EUDAMED before placing their devices on the market."
When Registration Is Required Anyway
"Exempted before placing on the market" is a narrower statement than "never has to register". MDCG 2021-13 rev.1 and the Commission's Q&A on the gradual roll-out of EUDAMED (the roll-out Q&A, below) each name two situations in which a manufacturer of only custom-made devices has to register as an actor after all.
| Trigger | What Happens |
|---|---|
| A Class III custom-made implantable device gets its first notified body certificate | Under Article 52(8) of the MDR, Class III custom-made implantable devices go through a notified body quality management system assessment, and the resulting certificate is entered in EUDAMED. The roll-out Q&A says these manufacturers "need to register in the ACT module to enable NB to register the QMS certificates", and MDCG 2021-13 rev.1 says the registration has to happen "in advance of the entering of the information in EUDAMED by the notified body regarding the first certificate". |
| The manufacturer submits its first vigilance report for a custom-made device | The roll-out Q&A says manufacturers who exclusively place custom-made devices on the market "need to register in the ACT module and receive an Actor ID before they can use other Eudamed modules, e.g. to report a serious incident regarding a custom-made device." MDCG 2021-13 rev.1 lists what counts: the first serious incident report, field safety corrective action with its field safety notice, or trend report submitted to EUDAMED "in respect of custom-made devices of any risk class". |
MDCG 2021-13 rev.1 adds two details. First, in these cases the registration duty also applies to non-EU manufacturers of only custom-made devices and to their authorised representatives. Second, a manufacturer or authorised representative of only custom-made devices is "assigned an Actor ID that is not a SRN". Under its Q8, that Actor ID is treated as an SRN only if the manufacturer later also places non-custom-made MDR devices, or IVDR devices, on the market.
Why the Device Itself Cannot Be Registered
The actor registration carve-out has a parallel in device registration. MDR Article 29 requires the manufacturer to enter device data in EUDAMED before placing a device on the market, "other than a custom-made device". The provision covering systems and procedure packs, MDR Article 29(2), has its own carve-out for a system or procedure pack "that is not a custom-made device". These are exceptions inside the registration duty itself, not an administrative choice EUDAMED happens to make.
The roll-out Q&A spells out what that means in practice: "Custom-made devices cannot be registered in the UDI/DEV module either." There is no device record, no UDI-DI and no EUDAMED DI for a custom-made device. The one exception is narrow and reactive: "If the custom-made device is the subject of a MIR or FSCA, the manufacturer will need to provide a limited device data set to submit the relevant report in the VGL module". That is enough device detail to attach a vigilance report to, and nothing more.
What Still Reaches EUDAMED
"Exempt from registration" does not mean a custom-made device generates no EUDAMED activity. Two things still reach the system. Two documents people expect to find there do not, for different reasons.
| What | Who Enters It, and When |
|---|---|
| Class III custom-made implantable quality management system certificate | The notified body enters the certificate under MDR Article 56(5), which requires notified bodies to enter certificate information in EUDAMED and makes it publicly accessible. The manufacturer registers as an actor first, so the notified body can link the certificate to it. |
| Serious incident reports and field safety corrective actions | MDCG 2021-3 states that, under Article 87(1) of the MDR, custom-made device manufacturers "shall report to the competent authorities any serious incidents and/or field safety corrective actions as soon as they learn of them". A manufacturer of only custom-made devices registers as an actor the first time this applies, then submits a limited device data set alongside the report. |
| Not a Summary of Safety and Clinical Performance | Article 32(1) of the MDR requires the summary for implantable devices and Class III devices "other than custom-made or investigational devices", and MDCG 2021-3 restates that it is not required for a custom-made device. There is no document to upload because the regulation does not require one to exist. |
| Not a PSUR in EUDAMED either | MDCG 2021-3 states that a custom-made device manufacturer must still draw up a post-market surveillance report (Class I) or a Periodic Safety Update Report (Classes IIa, IIb and III) and keep it as part of the device's Annex XIII documentation. The roll-out Q&A adds, in a footnote: "Legacy devices, custom-made devices and old devices do not require a PSUR in Eudamed." The law requires the document. EUDAMED does not collect it for this device category. |
One more role is easy to get wrong. MDCG 2021-3 confirms that custom-made device manufacturers must appoint a person responsible for regulatory compliance under MDR Article 15, but "they are not required to register these persons in EUDAMED".
In-House Devices: A Different Exemption
MDCG 2023-1 describes in-house devices as devices made and used within EU health institutions "on a non-industrial scale, to address the specific needs of target patient groups which cannot be met, or cannot be met at the appropriate level of performance, by an equivalent CE-marked device available on the market". The exemption is conditional on the health institution meeting every condition in Article 5(5), among them keeping the device within the same legal entity, operating under an appropriate quality management system, documenting why no equivalent CE-marked device meets the need, publishing a declaration, and keeping documentation and a corrective action process.
None of MDCG 2023-1's 20 pages describes an actor or device registration duty for the health institution. The reason is structural. MDR Article 29 and MDR Article 31 are both triggered by placing a device on the market, and an in-house device stays with the legal entity that made it. "If, during the lifecycle of the device, the device is used outside the health institution's legal entity, it cannot be in-house", per MDCG 2023-1.
One date gap applies to IVDs only. IVDR Article 5(5) is the IVDR's parallel provision, with extra IVD-specific conditions, and not every point of it applies yet. Point (d), which requires the health institution to justify in its documentation that the target patient group's needs cannot be met by an equivalent device available on the market, applies from December 31, 2030, under IVDR Article 113(3) as amended by Regulation (EU) 2024/1860. The MDR's Article 5(5) has applied in full since May 26, 2021.
IVDR: No Custom-Made Carve-Out
The sections above the in-house one are MDR-specific. They trace to the custom-made carve-outs written into MDR Article 31 and MDR Article 29. IVDR Article 28, the IVDR's own actor registration duty, has no such carve-out. Its first sentence reads: "Before placing a device on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 27 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article". There is no "other than a custom-made device" exception anywhere in it, and the IVDR does not define a custom-made device at all. An IVD manufacturer registers as an actor before placing its first device on the market.
What Goes Wrong
| Mistake | What Happens | Correct Approach |
|---|---|---|
| Treating "exempt from actor registration" as permanent | The first Class III custom-made implantable certificate, or the first vigilance report, requires an actor registration, and it has to be in place before that step | Track the two triggers separately and register as an actor before whichever comes first |
| Trying to register a custom-made device record in the UDI/Devices module | The roll-out Q&A states custom-made devices cannot be registered there | Prepare the Annex XIII statement and documentation instead; only a limited device data set accompanies a vigilance report, if one is ever needed |
| Applying the MDR's custom-made carve-out to an IVDR device | IVDR Article 28 has no custom-made exception and the IVDR defines no custom-made device; the manufacturer registers as an actor from the start | Check which regulation applies before assuming the custom-made exemption carries over |
| Calling an in-house device "custom-made" or vice versa | MDCG 2023-1 puts custom-made devices out of scope of Article 5(5); the two categories have different conditions, different documentation and different EUDAMED consequences | Confirm which category applies before relying on either exemption's rules |
| Assuming the custom-made exemption removes vigilance duties | MDCG 2021-3 states that serious incident and field safety corrective action reporting under Article 87(1) of the MDR still applies | Keep the vigilance process live for custom-made devices; only the pre-market registration steps are exempt |
Primary Sources
This guide is sourced to the regulation text, to MDCG guidance and to the Commission's EUDAMED roll-out Q&A, not to secondary summaries of them.
| Document | Covers |
|---|---|
| MDCG 2021-3, "Questions and Answers on Custom-Made Devices" (March 2021) | The custom-made device definition, the Annex XIII conformity route, the Class III implantable notified body certification, the SSCP exemption, PRRC and post-market surveillance obligations, and the vigilance reporting duty |
| MDCG 2021-13 rev.1, "Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR" (July 2021) | Confirms the actor registration carve-out, the two triggers that require registration anyway, and the Actor ID vs. SRN distinction for custom-made-only actors |
| "Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860" | Listed on the Commission's MDCG guidance page under November 2024; the link is to the Commission's current copy. It carries no MDCG number, and its own disclaimer says it has not been formally endorsed by the Commission. Confirms custom-made devices cannot be registered in the UDI/DEV module, names the two actor registration triggers, and states that custom-made devices do not require a PSUR in EUDAMED |
| MDCG 2023-1, "Guidance on the health institution exemption under Article 5(5)" (January 2023) | The in-house device exemption, its conditions, its exclusion of custom-made devices, and the non-industrial-scale limit |
The exemptions are real, and they are narrower than they sound. A custom-made device still generates a notified body certificate entry or a vigilance report the moment either is needed, and an in-house device stops being in-house the moment it leaves the health institution that made it. A manufacturer with a mixed catalogue also still has the November 27, 2026 deadline for the devices it places on the market that are not custom-made.
Frequently Asked Questions
Do manufacturers of custom-made devices have to register in EUDAMED?
Not before placing a device on the market. MDR Article 31 exempts custom-made devices from the pre-market actor registration duty that applies to manufacturers, authorised representatives and importers of other devices. The exemption is not permanent, though. MDCG 2021-13 rev.1 and the Commission's Q&A on the gradual roll-out of EUDAMED both say that a manufacturer of only custom-made devices has to register as an actor before it can use another EUDAMED module, most commonly to report a serious incident or field safety corrective action for the first time, or in advance of a notified body registering the quality management system certificate for a Class III custom-made implantable device.
Can a custom-made device be registered in the EUDAMED UDI/Devices module?
No. The Commission's Q&A on the gradual roll-out of EUDAMED states that custom-made devices cannot be registered in the UDI/DEV module. If a custom-made device becomes the subject of a serious incident report or field safety corrective action, the manufacturer provides a limited device data set so that the report can be submitted in the Post-Market Surveillance and Vigilance module. That is not a device registration.
Does a custom-made device need a Summary of Safety and Clinical Performance?
No. Article 32(1) of the MDR requires the summary for implantable and Class III devices other than custom-made or investigational devices, and MDCG 2021-3, the Medical Device Coordination Group's Q&A on custom-made devices, restates that a Summary of Safety and Clinical Performance is not required for a custom-made device. Class III custom-made implantable devices still go through a notified body quality management system certification, and that certificate is what the notified body enters in EUDAMED.
Is an in-house device the same thing as a custom-made device?
No. MDCG 2023-1 states that custom-made devices are out of scope of the in-house exemption in Article 5(5) and should follow the relevant requirements of the MDR. A custom-made device is made to a written prescription for one particular patient and is placed on the market through the Annex XIII route. An in-house device is made and used only inside one health institution under Article 5(5) of the MDR or IVDR, is not transferred to another legal entity, and so is never placed on the market.
Do custom-made device manufacturers still have to report serious incidents?
Yes. MDCG 2021-3 states that, under Article 87(1) of the MDR, custom-made device manufacturers shall report to the competent authorities any serious incidents and field safety corrective actions as soon as they learn of them. The actor registration and device registration carve-outs remove custom-made devices from EUDAMED's pre-market registration steps. They do not touch vigilance.
Does the IVDR exempt custom-made devices from actor registration the way the MDR does?
No. IVDR Article 28, the IVDR's actor registration duty, has no custom-made carve-out, unlike MDR Article 31, and the IVDR does not define a custom-made device at all. An IVD manufacturer registers as an actor under IVDR Article 28 before placing its first device on the market.