EU MDR Custom-Made Devices, Systems and Procedure Packs: Duties and Deadlines

1. Key takeaways

Custom-made devices are defined in Article 2(3), must be documented in accordance with Annex XIII and follow the corresponding procedure. Systems and procedure packs are governed by Article 22, under which the integrator issues a declaration and assumes the corresponding obligations. Class III custom-made implantable devices could originally be placed on the market without a notified body certificate until 2026-05-26 under Article 120(3f), and that period has now expired.

These three regimes are frequently mixed up in practice, yet they answer different questions. The custom-made regime defines devices made for a specific patient and governs their documentation and procedures; it is a distinct pathway, not an absence of regulation. The systems and procedure packs regime addresses the combination of CE-marked devices into sets placed on the market by an entity that did not manufacture the components, and it assigns that entity obligations resembling those of a manufacturer. The transitional provision for Class III custom-made implantables was a temporary bridge with fixed conditions and a fixed end date. Businesses active in orthopaedics, dentistry or surgical logistics need to know precisely which of the three regimes applies to each product line, because the documentation, the declarations and the deadlines differ in every case.

2. Legal basis

The custom-made and systems regimes are anchored in Regulation (EU) 2017/745, adopted on 2017-04-05 and applicable since 2021-05-26. The transitional provision in Article 120(3f) was introduced by Regulation (EU) 2023/607, adopted on 2023-03-15 and in force from 2023-03-20, which amended Article 120. Article 52(8) defines the conformity assessment that applies to custom-made devices, including the certificate requirement that became decisive once the transitional window closed in May 2026.

3. Expert insights

Insight one: a custom-made device does not mean conformity assessment does not apply.

Custom-made devices have dedicated documentation requirements under Annex XIII and dedicated procedure requirements under Article 52(8); what they generally lack is full notified body review of every individual product in certain situations. Treating them as unregulated products leads directly to missing files and missed registrations. The declaration, the production records and the information supplied to the patient or the healthcare professional are all mandatory elements, and market surveillance authorities actively check for them. Manufacturers entering the custom-made space should design the documentation system before the first device is produced, since retrofitting patient-specific records after production is far more expensive and less credible than maintaining them contemporaneously.

Insight two: the transitional period for Class III custom-made implantable devices expired on 26 May 2026.

Under Article 120(3f), Class III custom-made implantable devices could be placed on the market until 2026-05-26 without a certificate under the second subparagraph of Article 52(8), provided a formal application was submitted before 2024-05-26 and a written agreement was signed before 2024-09-26. That date has expired, and from 2026-05-27 such devices require the corresponding certificate. This is a window that closed within the last two years, with direct consequences for orthopaedic and dental custom implant businesses. Operators who used the window should confirm the certificate status of every product line, and operators who missed the window must suspend placement until the Article 52(8) assessment is complete.

Insight three: the integrator of systems and procedure packs carries independent manufacturer-type obligations.

Under Article 22, an entity that combines CE-marked devices into a system or a procedure pack and places it on the market must perform verification of the integration, issue a declaration, assume the corresponding obligations and accept the constraints of the packaging and labelling rules. The integrator is not a distributor; the obligations are closer to those of a manufacturer. This distinction matters for liability, for documentation and for the economic operator registration. Distributors who assemble sets as a value-added service without registering as integrators and without issuing declarations create a compliance gap that market surveillance authorities treat seriously.

Insight four: the post-market obligations for custom-made devices are not waived.

Custom-made devices remain subject to post-market surveillance and vigilance obligations, and the PSUR, where applicable, forms part of the documentation under Section 2 of Annex XIII. A common misconception is that custom products do not need a PSUR, which creates a compliance gap that only becomes visible when the competent authority requests the file. Since custom-made devices are produced for individual patients, the post-market experience of each device is the only systematic source of safety information for the technology, making the surveillance obligations proportionate rather than burdensome. Operators should integrate custom-made devices into the same PMS and vigilance workflows used for series production, without exemption exceptions.

4. Practical recommendations

1. Build a file for every custom-made device order, recording the design basis, the patient-matching information and the declaration in accordance with the Annex XIII requirements.
2. For Class III custom-made implantable businesses, check immediately whether the certificate under Article 52(8) has been obtained; devices without it must not continue to be placed on the market after 2026-05-26.
3. For systems and procedure packs, establish an integration verification checklist covering compatibility, sterilisation, packaging, labelling, instructions for use and the declaration.
4. Include custom-made devices in the PMS and vigilance processes without exemption exceptions, and file the PSUR where Annex XIII Section 2 requires it.
5. Verify and record that every component included in a procedure pack is a CE-marked compliant device, keeping the verification records with the pack documentation.

5. Verification checklist

• □ Whether each product is a custom-made device under Article 2(3) has been determined
• □ The custom-made device files comply with the requirements of Annex XIII
• □ The Article 52(8) certificate status of Class III custom-made implantables has been checked (required after 2026-05-26)
• □ Systems and procedure packs have completed integration verification and the declaration has been issued
• □ The CE compliance status of every component in the packs has been verified individually
• □ Custom-made devices have been included in the PMS and vigilance processes

GRZAN supports manufacturers, authorised representatives and importers across the EU MDR market with CE marking pathway selection and classification strategy, including custom-made device documentation under Annex XIII, Article 52(8) certificate projects for Class III custom-made implantables, and Article 22 integrator compliance for systems and procedure packs. For a practical estimate of timelines and documentation effort for your portfolio, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 2026-10-29.