Service
MDR / IVDR compliance counsel.
The MDR and IVDR govern medical devices and in-vitro diagnostics placed on the EU market; the MepV governs the Swiss market. The firm provides ongoing legal compliance support (post-market surveillance and vigilance review, authorised-representative and PRRC contract maintenance, EUDAMED queries) and structures CH-REP mandates and Swiss market entry for manufacturers without a Swiss presence. It advises; it does not act as the representative.
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.
What's included
- 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 (Arts. 85–86 MDR; Arts. 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).
- AR / PRRC contract maintenance: drafting and upkeep of authorised-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; operational detail is confirmed against current guidance at engagement, as EUDAMED is still being phased in.
- CH-REP mandate structuring: Swiss market-entry structuring under Art. 51 MepV for manufacturers without a seat in Switzerland. The firm structures and advises on the mandate; it does not act as the representative.
- Discrete fixed-fee modules: AR/PRRC agreement packages, Article 16 economic-operator structuring (relabelling and repackaging under Art. 16 MDR), and labelling review, delivered as scoped fixed-fee workstreams.
How it works
- Scoping. The firm maps the device portfolio, risk classes, target markets (EU / Switzerland) and the economic-operator chain.
- Role allocation. The firm determines where authorised-representative, CH-REP, importer and PRRC roles are required and how obligations are allocated under Art. 16 MDR.
- Gap assessment. The firm compares existing post-market, vigilance and contractual documentation against the MDR, IVDR and MepV obligations.
- Documentation. The firm drafts or refreshes the AR/PRRC agreements, the CH-REP mandate and the labelling and economic-operator structures as fixed-fee modules.
- Ongoing advisory. The firm supports post-market surveillance, vigilance reporting and EUDAMED queries on a retainer.
Indicative pricing
Subscription + fixed-fee modules
from CHF 5,500 / month
Discrete workstreams as fixed-fee modules, CHF 4,500 to 14,000.
Indicative starting prices, net and exclusive of Swiss MWST (VAT) where applicable; final fee per written engagement letter.
Frequently asked questions
- Does a manufacturer outside the EU need an authorised 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 authorised 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 authorised representative, and a separate Swiss representative for the Swiss market. The firm structures and reviews these mandates; it does not act as the representative.
- What is the difference between the EU authorised representative and the Swiss CH-REP?
- They are two distinct mandates under two legal regimes. The EU authorised representative is required by Art. 11 MDR / Art. 11 IVDR for manufacturers not established in the Union. The Swiss authorised representative (CH-REP) is required by Art. 51 MepV for manufacturers without a seat in Switzerland: 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. 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), producing a post-market surveillance report for class I devices (Art. 85) and a periodic safety update report (PSUR) for class IIa, IIb and III devices (Art. 86). Serious incidents and field safety corrective actions must be reported to the competent authorities under Art. 87 MDR. The IVDR mirrors this structure in Arts. 78–81 and Art. 82. The firm reviews these processes and their documentation as legal counsel; the underlying clinical and technical work remains with the manufacturer.
- Does the firm act as the authorised representative or PRRC?
- No. The firm provides legal counsel: it structures, drafts and reviews the authorised-representative and person-responsible-for-regulatory-compliance (PRRC) agreements, the CH-REP mandate under Art. 51 MepV, and the related economic-operator allocation under Art. 16 MDR. It does not itself act as the authorised representative, the CH-REP or the PRRC, and it does not assume the regulatory liability those roles carry. Discrete workstreams (AR/PRRC agreement packages, Article 16 economic-operator structuring, and labelling review) are available as fixed-fee modules.