This case study is a composite illustration based on the types of compliance failures TGC regularly encounters when working with medical device manufacturers entering or maintaining access to EU, UK, US, and Chinese markets. The company, market scenario, and financial figures are fictionalised for instructional purposes, but every regulatory failure described reflects a real pattern of non-conformity seen across the industry during the EU MDR transition period.
The manufacturer in question — Hansung Surgical Technologies, a South Korean producer of Class IIa reusable surgical instruments — had been selling into the EU market successfully for nine years under MDD 93/42/EEC certification. When the EU Medical Device Regulation replaced the MDD, the company's EU distributor reassured them that their existing certificate "still had time." That assessment was technically accurate in 2021. By 2026, it was not.
The Product and Its Markets
Hansung's flagship product line — a range of Class IIa reusable laparoscopic graspers and scissors — was certified under MDD Annex II (full quality assurance) by a Dutch Notified Body in 2019, with a certificate valid until 2024. The product was distributed in Germany, the Netherlands, and Belgium through a single European distributor. Simultaneously, the same product line was cleared by the US FDA under a 510(k) submission and sold in the US through a separate distributor. Hansung had no direct relationship with either market authority — all regulatory filings had historically been managed by their distributors.
This distributor-led compliance model — common among mid-sized Asian device manufacturers — is the first structural risk that this case study examines. When it breaks down, it breaks down completely.
Failure One: The MDD Certificate Was Not Transitioned to MDR
Hansung's MDD certificate expired in March 2024. In the period leading up to expiry, the Dutch Notified Body — under significant pressure from a dramatically increased MDR workload — had communicated that Hansung would need to submit a full MDR conformity assessment application to continue on the EU market. The distributor acknowledged the communication but did not escalate it to Hansung's regulatory affairs team in Seoul.
When the certificate lapsed, the European distributor continued placing the product on the market, relying on existing stock in the EU supply chain. This is a practice that market surveillance authorities had been monitoring closely since 2024, and the German Federal Institute for Drugs and Medical Devices (BfArM) — which maintains active import surveillance at major distribution centres — flagged the product during a routine check in October 2025.
Under EU MDR 2017/745, Article 10 places the obligation to ensure conformity squarely on the manufacturer. Placing a Class IIa device on the EU market without a valid MDR certificate — after the relevant transitional provisions under Regulation (EU) 2023/607 had been exhausted for that certificate — constitutes a direct violation of the MDR. BfArM initiated a formal non-conformity procedure, requiring the distributor to cease placing the product on the market immediately and to account for all units in the supply chain.
Failure Two: No EUDAMED Registration
While investigating the certificate lapse, BfArM also identified that neither Hansung nor their EU distributor had completed EUDAMED registration for either the manufacturer or the device. Commission Decision (EU) 2025/2371 had established EUDAMED registration as mandatory from 28 May 2026 — and Hansung's situation was discovered in October 2025, giving them some technical time before that deadline. However, the absence of an EU Authorised Representative registered in EUDAMED was a separate and already-actionable issue.
Hansung had never formally appointed an EU Authorised Representative as required under Article 13 of the MDR. Their Dutch distributor had been acting as an informal point of contact for regulatory matters — a practice that was technically compliant under the old MDD model (where an EC Authorised Representative was not required in the same formal sense) but is not compliant under the MDR. The MDR requires the EU AR to be a formally designated legal entity, with written mandate, registered in EUDAMED, and with their name and address appearing on the device label. None of these elements were in place.
This meant that even if Hansung had been able to resolve the MDR certificate issue rapidly, they would still have been unable to legally place the product on the EU market without first appointing and registering an EU AR in EUDAMED. These are sequential requirements — a device cannot be placed on the EU market without a registered EU AR — and the appointment and EUDAMED registration process takes time that Hansung did not have.
Failure Three: The QMSR Gap in the US
Hansung's US 510(k) clearance was current. However, when the FDA's revised Quality Management System Regulation (QMSR) became effective on 2 February 2026 — incorporating ISO 13485:2016 by reference into the revised 21 CFR Part 820 — Hansung's QMS documentation remained written against the legacy 21 CFR Part 820 format from their original 510(k) submission in 2016.
A routine FDA inspection of Hansung's US distributor's facility in March 2026 included a review of Hansung's quality system documentation as part of the distributed device assessment. The inspector identified that the QMS documentation did not reflect the QMSR requirements — specifically, the ISO 13485:2016 management review structure, the supplier qualification records in the format required under QMSR, and the CAPA documentation that had not been updated to reflect the QMSR's more explicit requirements. These were issued as Form 483 observations, requiring a written response within 15 days and a remediation plan.
At this point, Hansung was simultaneously managing an EU market withdrawal, an EU AR appointment process, an EUDAMED registration backlog, and a US FDA inspection response — without a dedicated regulatory affairs resource capable of handling any of the four simultaneously.
The Chain of Events
March 2024 — MDD certificate expires. Dutch Notified Body notifies distributor that MDR submission is required to continue. Distributor fails to escalate to Hansung's regulatory affairs team in Seoul.
March 2024 – October 2025 — products continue to be placed on the EU market from existing stock. Distributor treats remaining inventory as already-compliant and continues shipping from their warehouse.
October 2025 — BfArM market surveillance identifies the lapsed MDD certificate during a customs documentation check at a Hamburg distribution centre. Non-conformity procedure initiated under EU MDR Article 95.
October 2025 — BfArM also identifies the absence of a registered EU Authorised Representative and the absence of any EUDAMED registration. The distributor's role as informal point of contact is found to be insufficient under MDR Article 13.
November 2025 — Hansung initiates an emergency EU AR appointment process and begins EUDAMED registration. MDR Notified Body application submitted. All EU market supply suspended during remediation.
February 2026 — FDA QMSR effective date passes with Hansung's QMS documentation not yet updated. The QMS was written against the legacy 21 CFR Part 820 format from the 2016 510(k) submission.
March 2026 — FDA inspection of US distributor facility surfaces QMSR non-conformance in Hansung's quality system documentation. Form 483 observations issued. 15-day written response required.
April 2026 — Hansung's EU AR is registered in EUDAMED; MDR Notified Body assessment is underway but expected to take 14–18 months given current Notified Body queues. EU market re-entry not expected before late 2027.
The Cost of Non-Compliance
| Cost Category | Description | Estimated Cost |
|---|---|---|
| EU market revenue loss | Estimated 18–24 months of EU market suspension during MDR Notified Body assessment and EUDAMED remediation | €210,000 |
| Stock withdrawal and destruction | Recall and withdrawal of non-compliant units from EU distribution chain; destruction of expired stock | €48,000 |
| Emergency EU AR appointment | Expedited EU AR service, formal mandate drafting, legal review, EUDAMED registration management | €22,000 |
| MDR Notified Body assessment | Notified Body application fees, technical documentation preparation, clinical evaluation report update, gap assessment | €65,000 |
| FDA QMSR gap remediation | QMS documentation update to QMSR format, management review restructuring, CAPA documentation revision, FDA response preparation | €28,000 |
| External regulatory counsel | Legal and regulatory advice across EU and US enforcement matters; coordinating parallel responses | €18,000 |
| Total estimated cost | Revenue loss plus direct remediation expenditure | €391,000 |
The Regulatory Facts Behind Each Failure
MDR Transition — Regulation (EU) 2023/607
The MDR transitional provisions allow devices with valid MDD certificates on 26 May 2021 to continue on the EU market until the transition cut-off dates — but only if the certificate remains valid and has not expired. Hansung's MDD certificate expired in March 2024. At that point, the transitional provisions ceased to apply. The device could not legally be placed on the EU market after certificate expiry without a valid MDR certificate. This is a common misunderstanding: the transition deadlines of December 2027 and December 2028 are cut-off dates for valid MDD certificates — they do not extend certificates that have already lapsed.
EU Authorised Representative — MDR Article 13 and EUDAMED
Article 13 of the MDR requires non-EU manufacturers to designate a single EU Authorised Representative by means of a written mandate. The EU AR must be registered in EUDAMED and their name and address must appear on or with the device. The distributor — even one that has historically handled regulatory matters — is not an EU AR unless they have been formally designated under a written Article 13 mandate. Commission Decision (EU) 2025/2371 made EUDAMED registration mandatory from 28 May 2026, but the EU AR requirement under Article 13 of the MDR has been active since the MDR's date of application on 26 May 2021.
FDA QMSR — Revised 21 CFR Part 820 Effective 2 February 2026
The QMSR became effective on 2 February 2026, incorporating ISO 13485:2016 by reference. All FDA-registered establishments must now operate under a QMSR-compliant quality system. QMS documentation written against the legacy 21 CFR Part 820 QSR format — which predated ISO 13485 incorporation — does not satisfy QMSR requirements. The transition period of two years (from publication of the final rule on 2 February 2024) was provided specifically to allow manufacturers time to update their QMS documentation. Manufacturers who did not use that period are now operating out of compliance.
What Could Have Prevented This
- A proactive MDR gap assessment in 2022 or 2023 — before the MDD certificate expired — would have identified the need to initiate a Notified Body application and EU AR appointment at a time when Notified Body capacity was more accessible and the cost of remediation was a fraction of the eventual total.
- A formal EU Authorised Representative appointment under a written Article 13 mandate from the date the MDR became applicable (26 May 2021) would have satisfied the EU AR requirement and eliminated that enforcement exposure entirely.
- A QMSR readiness assessment in 2024 or 2025 — during the two-year transition period — would have identified the QMS documentation gaps against ISO 13485:2016 requirements and allowed remediation before the effective date, avoiding the Form 483 findings entirely.
- A centralised, manufacturer-owned compliance calendar — rather than distributor-delegated regulatory management — would have ensured that certificate expiry dates, EUDAMED registration deadlines, and QMSR transition milestones were tracked by a party with direct accountability to Hansung's regulatory obligations.
- A multi-market compliance review in early 2026 — recognising that the EU, UK, US, and China obligations were all simultaneously active — would have allowed Hansung to coordinate their response to the EUDAMED mandate, the QMSR effective date, and the MDR transition cut-offs in a planned sequence rather than as a reactive crisis.
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