GAWEL LEGAL

MDR and IVDR compliance

GAWEL Legal provides MDR and IVDR compliance counsel to device and IVD manufacturers for EU and Swiss (MepV, IvDV) markets, on a retainer. The retainer covers post-market surveillance and vigilance review, authorized-representative and PRRC contracts and EUDAMED queries; GAWEL Legal structures CH-REP mandates and does not act as the representative.

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Documentation across two markets
EU devices and IVDs
MDR and IVDR
Swiss market
MepV and IvDV
After market entry
Surveillance and vigilance
Representative arrangements
AR, CH-REP and PRRC agreements

GAWEL Legal advises on these roles; it does not act as the representative or PRRC.

Who this is for

  • Swiss MedTech SMEs exporting devices or in vitro diagnostics to the EU market
  • Non-EU manufacturers entering the Swiss and EU markets in parallel
  • Manufacturers needing ongoing post-market, vigilance and representative-contract support without an in-house regulatory legal function

Scope

  • Post-market surveillance review:
    legal review of the post-market surveillance system (Art. 83 MDR; Art. 78 IVDR), its plan (Art. 84 MDR; Art. 79 IVDR), and the resulting reports and periodic safety update reports (Art. 85–86 MDR; Art. 80–81 IVDR)
  • Vigilance legal review:
    the legal framework for reporting serious incidents and field safety corrective actions to the competent authorities (Art. 87 MDR; Art. 82 IVDR), and the manufacturer's underlying obligations (Art. 10 MDR)
  • Supply interruption notices:
    the advance notice owed to the competent authority and to direct customers where an interruption or discontinuation of supply could seriously harm patients or public health (Art. 10a MDR; Art. 10a IVDR)
  • AR / PRRC contract maintenance:
    drafting and upkeep of authorized-representative agreements (Art. 11 MDR; Art. 11 IVDR) and person-responsible-for-regulatory-compliance arrangements
  • EUDAMED queries:
    legal interpretation of EUDAMED registration and economic-operator obligations; use of the first four EUDAMED modules has been mandatory since 28 May 2026, and the remaining modules are still being phased in.
  • CH-REP mandate structuring:
    Swiss market-entry structuring under Art. 51 MepV (Art. 44 IvDV for in vitro diagnostics) for manufacturers without a seat in Switzerland. GAWEL Legal structures and advises on the mandate; it does not act as the representative.
  • Fixed-fee modules:
    AR/PRRC agreement packages, economic-operator structuring under Art. 16 MDR and Art. 16 IVDR (relabeling and repackaging), and labeling review, provided as separately scoped fixed-fee assignments

How the work proceeds

  1. Scoping The initial review maps the device portfolio, risk classes, target markets (EU / Switzerland) and the economic-operator chain.
  2. Role allocation The review determines where authorized-representative, CH-REP, importer and PRRC roles are required and how obligations are allocated under Art. 16 MDR and Art. 16 IVDR.
  3. Gap assessment Existing post-market, vigilance and contractual documentation is compared against the MDR, IVDR, MepV and IvDV obligations.
  4. Documentation AR/PRRC agreements, the CH-REP mandate and the labeling and economic-operator structures are drafted or refreshed as fixed-fee modules.
  5. Ongoing advisory The retainer covers legal support for post-market surveillance, vigilance reporting and EUDAMED queries.

Fees

Retainer + fixed-fee modules

Separately scoped assignments run as fixed-fee modules alongside the retainer.

Questions

Does a manufacturer outside the EU need an authorized representative under the MDR or IVDR?
Yes. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorized representative (Art. 11(1) MDR; Art. 11(1) IVDR). The designation constitutes the representative's mandate and is valid only when accepted in writing. A Swiss or US manufacturer selling into the EU therefore needs an EU authorized representative; a manufacturer without a seat in Switzerland, such as a US manufacturer, also needs a separate Swiss representative for the Swiss market (Art. 51 Abs. 1 MepV; Art. 44 Abs. 1 IvDV). GAWEL Legal structures and reviews these mandates; it does not act as the representative.
What is the difference between the EU authorized representative and the Swiss CH-REP?
They are two distinct mandates under two legal regimes. The EU authorized representative is required by Art. 11 MDR / Art. 11 IVDR for manufacturers not established in the Union. The Swiss authorized representative (CH-REP) is required for manufacturers without a seat in Switzerland by Art. 51 MepV and, for in vitro diagnostics, by Art. 44 IvDV: products may only be placed on the Swiss market if such a manufacturer has mandated, in writing, a person seated in Switzerland, whose rights and obligations follow Art. 11 MDR or, for in vitro diagnostics, Art. 11 IVDR. Since the Mutual Recognition Agreement on medical devices lapsed, the EU and Swiss representative roles must be staffed separately.
What post-market and vigilance obligations does the MDR impose after a device is on the market?
The manufacturer must plan, establish and maintain a post-market surveillance system proportionate to the risk class (Art. 83 MDR), based on a post-market surveillance plan (Art. 84 MDR), producing a post-market surveillance report for class I devices (Art. 85 MDR) and a periodic safety update report (PSUR) for class IIa, IIb and III devices (Art. 86 MDR). Serious incidents and field safety corrective actions must be reported to the competent authorities under Art. 87 MDR. The IVDR mirrors this structure in Art. 78–81 and Art. 82 IVDR. GAWEL Legal reviews these processes and their documentation as legal counsel; the underlying clinical and technical work remains with the manufacturer.
Does GAWEL Legal act as the authorized representative or PRRC?
No. GAWEL Legal provides legal counsel: it structures, drafts and reviews the authorized-representative and person-responsible-for-regulatory-compliance (PRRC) agreements, the CH-REP mandate under Art. 51 MepV (Art. 44 IvDV for in vitro diagnostics), and the related economic-operator allocation under Art. 16 MDR (Art. 16 IVDR for in vitro diagnostics). It does not itself act as the authorized representative, the CH-REP or the PRRC, and it does not assume the regulatory liability those roles carry. Separately scoped fixed-fee modules (AR/PRRC agreement packages, economic-operator structuring under Art. 16 MDR and Art. 16 IVDR, and labeling review) are available alongside the retainer.

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Last updated: 4 October 2026

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