In-House and Custom-Made Devices: The Narrow Paths of Art. 9, 18 and 19

This article is number 08 in Volume 1, Regulatory Framework and Fundamentals, of the fifty-part series on medical device registration in Switzerland. Together with the other nine articles in this volume it forms a complete deliverable on this topic. The publication timestamp, article number, article title and unique URL are listed in the table below.

1. Key takeaways

In-house devices and custom-made devices are two narrow paths with a shared feature: the conformity mark is exempted, but notification is not. MedDO Art. 13(2) states expressly that these two categories of devices must not bear a conformity mark, yet Art. 18 and Art. 19 still require notification to Swissmedic before they are put into service or placed on the market. Reading the absence of a conformity mark as freedom from regulation is the most common error on both paths, and it surfaces precisely at market surveillance, where the missing notification file is the first item an inspector requests. Maintaining a complete notification ledger for these categories is therefore the cheapest insurance available.

2. Legal basis

Verification entry points: MedDO Article 9 (in-house devices), Article 18 (custom-made devices) and Article 19 (custom-made device statement and notification), together with the two Swissmedic notification forms and the FAQ Notifications listed above. Keeping the form versions alongside the ordinance citations ensures that notifications are filed on the templates Swissmedic actually accepts at the time of filing.

3. Expert insights

1. Art. 13(2) lists five categories that must not bear a conformity mark: custom-made devices, devices for demonstration, systems and procedure packs, devices for clinical investigation, and Art. 9 devices. Conclusion: going without a mark only removes the marking step from the compliance sequence; the scope provisions, product information and vigilance obligations do not disappear with it. The trade-off: the savings in printing and process effort are modest, while the cost of a missed notification or a misjudged case of applicability is far higher, so the value of these narrow paths lies in using them when there is a genuine need, not in escaping compliance.
2. For in-house devices (Art. 9 plus Art. 18), the decisive question is definitional fit. Art. 9 lists in-house devices of healthcare institutions separately, Art. 13(2)(e) cites it so that they become one of the no-mark categories, and Art. 18 requires notification before they are put into service. Conclusion: applicability depends on whether the device falls within the Art. 9 definition; once it exceeds that definition, for example by becoming an external supply, the notification route and the conformity assessment requirements change accordingly, and the full CE route may apply from that point onward. The counterpoint: running in-house devices as a routine product line invites demands at market surveillance to complete the full compliance chain retroactively, and the disruption to clinical operations is usually far greater than the effort of a timely notification.
3. Custom-made devices (Art. 19) carry one language exception. Art. 16(3) lists devices for custom-made or in-house use among the cases where the number of languages may be reduced or English may be used. Conclusion: this is only one of four conditions; it must be accompanied by users having the necessary professional and language competence and giving consent, protection of patients, users and third parties remaining assured, and effectiveness and intended use not being impaired. Equating custom-made with an English-only instruction for use is a misreading, and each of the remaining conditions should be evidenced before the simplified language scheme goes into print.

4. Practical recommendations

1. Start with a written characterisation: compare the facts against the Art. 9 definition item by item, confirm whether the device is truly an in-house device, and record the conclusion and version date.
2. Complete the Art. 18 notification for in-house devices before they are put into service, and retain the Swissmedic receipt evidence.
3. Notify custom-made devices under Art. 19 using form BW630_30_026e_FO, and maintain a notification ledger per project.
4. Where languages are to be reduced or English used, document the evidence for each of the four Art. 16(3) conditions in writing and obtain user consent.
5. Devices for demonstration and devices for clinical investigation likewise must not bear a conformity mark; include them in the outbound and exhibition management lists.

5. Verification checklist

• □ The applicability of in-house device status has been characterised in writing against Art. 9 and recorded
• □ The Art. 18 notification was completed before putting into service, with receipt evidence retained
• □ Custom-made devices were notified using form BW630_30_026e_FO (Art. 19)
• □ In-house, custom-made, demonstration, systems and procedure packs, and clinical investigation devices all bear no conformity mark (Art. 13(2))
• □ Any language reduction or English scheme is supported by written evidence of the four Art. 16(3) conditions
• □ The reporting path for serious incidents discovered by users is implemented under TPA Art. 59

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers and economic operators entering the Swiss market with end-to-end Swissmedic registration and compliance services, including in-house and custom-made device characterisation, Art. 18 and Art. 19 notifications on the current Swissmedic forms, Art. 16(3) language exception documentation, and market surveillance readiness for no-mark device categories. For tailored guidance on your product portfolio, contact info@grzanglobal.com.