Two Roles, One Responsibility
EU-REP/EC-REP, CH-REP, and PRRC are interlinked—only together can they ensure long-term market access.
EU Authorised Representative · EU-REP/EC-REP Swiss Authorised Representative · CH-REP PRRC · Art. 15
Your Authorised Representative for the EU and Switzerland— From a Mandatory Requirement to a Valuable Partner
An authorised representative is required by law and must do more than just serve as a "mailbox service". Metecon handles EU-REP/EC-REP, CH-REP, and PRRC roles and combines them with comprehensive regulatory expertise to ensure your market access in the EU and Switzerland remains robust.
EU + CH
EU-/EC-REP (via CEyoo GmbH) and CH-REP (Metecon Schweiz GmbH), both part of the same corporate group
CHRN-AR-20003994
Metecon Switzerland registered as a swiss authorised representative
Art. 11 & 15
authorised representative and PRRC covered under the MDR/IVDR
EUDAMED · swissdamed
registration & data maintenance in both registers
Positioning
Why an Authorised Representative Should Do More Than the Legal Minimum
Metecon assumes regulatory roles and responsibilities on behalf of manufacturers based outside the EU or Switzerland and establishes robust structures for market access. We combine the role of authorised representative with in-depth operational regulatory expertise.
Transactional Authorised Representative Mailbox Authorised Representative + Full Regulatory Expertise – All from a Single Source (Metecon)
Three Challenges—and How Metecon Can Help You
Three real-world problems that arise when there is no single authorised representative with overall responsibility, and how we solve them for you.
No Market Access Without a Representative & Registration
Market entry is not possible without an authorised representative and without registration in EUDAMED/swissdamed.
For you: We’ll appoint the right REP and handle the registration.
Unclear Responsibilities & Escalation Procedures
Ongoing responsibilities, points of contact, and escalation procedures are not consistently defined.
For you: We define responsibilities, deadlines, and reporting procedures in a binding manner.
Unmanaged Regulatory Risks
Risks in the target market are not managed centrally—market availability is at risk.
For you: We centrally manage communications with regulatory authorities, pharmacovigilance, and regulatory changes.
Roles in the Market: Who Has Which Responsibilities?
The authorised representative serves as the legal liaison between you, as a manufacturer outside the target market, and the authorities.
| Manufacturers MePV Art. 46–50 / IvDV Art. 39-43 → MDR/IVDR Art. 10 |
Authorised Representative (CH-/EU-/EC-REP) Authorised Representative (CH-/EU-REP/EC-REP) — MePV Art. 51 / IvDV Art. 44 → MDR/IVDR Art. 11/12; MePV Art. 55 / IvDV Art. 48 → MDR Art. 31 / IVDR Art. 28; PRRC MePV Art. 52 / IvDV Art. 45 MDR/IVDR Art. 15 (6) |
Importer MePV Art. 53 / IvDV Art. 46 → MDR/IVDR Art. 13 |
Distributor MePVArt. 54 / IvDV Art. 47 → MDR/IVDR Art. 14 |
Clear Distinction
What the manufacturer handles—and what we take care of
An authorised representative assumes responsibility for formal and safety-related tasks—however, certain manufacturer obligations under MDR/IVDR Article 10 and MepV Articles 46–50 / IvDV Articles 39–43 cannot be delegated.
Drawing this line clearly helps prevent compliance gaps.
Cannot be delegated—remains with the manufacturer (Art. 10)
- Compliant design & manufacturing; documented risk management
- Clinical evaluation (MDR Art. 61, MepV Art. 21) or performance evaluation (IVDR Art. 56, IvDV Art. 17), including post-market surveillance
- Preparation and maintenance of technical documentation
- Conformity assessment (if applicable, with a Notified Body / Designated Body), CE marking & Declaration of Conformity
- UDI system (Basic UDI-DI/UDI-PI) and registration as an economic operator
- QM system, PMS system, vigilance including FSCA/CAPA
- Financial coverage of liability (MDR/IVDR Art. 10, MepV Art. 50 / IvDV Art. 43)
Upon request, Metecon can also assist you with these manufacturer obligations —going beyond the role of authorized representative and providing a one-stop solution.
Liability of the Authorised Representative
Pursuant to Article 11(5) of the MDR/IVDR, Article 51 of the MepV, and Article 44 of the IvDV, the authorised representative is jointly and severally liable with the manufacturer for defective products.
Competency Matrix: Full REP Performance Instead of a Minimal Mandate
The criteria by which an authorised representative must be evaluated—
and how Metecon meets them (compared to a purely transactional provider).
| Competency Criterion | Metecon (EU-REP/EC-REP + CH-REP + PRRC) | Typical AR mailbox |
| Formal review of the declaration of conformity and technical documentation | ✓ Complete | ✓ |
| Registration & data maintenance: EUDAMED (SRN/Actor) and swissdamed (CHRN) | ✓ EU + CH | sometimes EU only |
| Pharmacovigilance contact point & communication with authorities (Swissmedic / Competent Authority) |
✓ | ✓ |
| Rapid response to incidents / inquiries from authorities | ✓ prioritized | varying |
| Retention of technical documentation (10–15 years) | ✓ | ✓ |
| Separate PRRC pursuant to Art. 15 (for ARs and manufacturers) | ✓ | sometimes |
| Transparent and secure liability (Art. 11, (5); product liability/D&O) | ✓ | ✓ | ✓ | ✓ |
| Data integrity of swissdamed (separate from EUDAMED) | ✓ | ✓ | ✓ | ✓ |
| EU and Swiss mandates from a single corporate group | ✓ CEyoo + Metecon Switzerland | often separate |
| Comprehensive regulatory consulting (technical documentation, risk management, PMS, QMS) | ✓ Differentiators | limited |
The selection criteria are based on the strengths of leading providers.
Metecon meets these benchmarks and complements them with end-to-end regulatory consulting from a single source for the EU and Switzerland.
Key Deadlines for 2026: Why You Should Take Action Now
Status of the review: August 2026.
EUDAMED and swissdamed will become mandatory at the same time—and must be maintained separately.
| May 28, 2026 | EU: first four EUDAMED modules become mandatory—registration of economic operators (SRN), UDI/product registration, Notified Bodies & certificates, market surveillance. New products must be registered before being placed on the market. |
| July 1, 2026 | Switzerland: swissdamed product registration is mandatory (transition period until Dec. 31, 2026). The actors module (CHRN) has been mandatory since August 2024. The CH-REP is responsible for data integrity. |
| November 28, 2026 | EU: Eudamed registration of existing/legacy products that continue to be marketed. |
| Date unknown | Switzerland: A renegotiation of the MRA is currently being prepared at the political level and could change the CH-REP requirement in the future—until then, a CH-REP remains mandatory for foreign manufacturers. |
EU-REP/EC-REP, CH-REP, and PRRC in Detail
Three roles with defined responsibilities. Select the role that applies to you.
EU Authorised Representative (EU-REP/EC-REP)
Swiss Authorised Representative (CH-REP)
PRRC (Art. 15)
EU Authorised Representative (EU-REP/EC-REP) pursuant to Article 11 of the MDR/IVDR
Manufacturers based outside the EU require an EU authorised representative in order for their medical devices or IVDs to be placed on the market. Metecon provides this service through its sister company, CEyoo GmbH—acting as the legal interface with EU authorities, backed by our comprehensive legal expertise.
Registration: EUDAMED + national registries
Initial registration prior to first placing on the market: Actor/SRN registration in EUDAMED, link to manufacturer and products—plus additional national registration, if applicable. Changes (address, PRRC) within one week.
Formal Document Review
Verification that a declaration of conformity, technical documentation, and conformity assessment are available—without assuming the manufacturer’s obligations under Article 10.
Labeling & Declaration of Conformity
Ensurance that the labeling and declaration of conformity include the name, trade name (if applicable), and address of the EU authorized representative.
Feedback from the Market
Prompt forwarding of complaints and incident reports to the manufacturer; forwarding of communications with the authorities (regarding risk, FSCA, samples/access) and ensurance that their requests are carried out.
Traceability & Retention
Cooperation with importers/distributors to ensure traceability (Art. 25 / IVDR Art. 22); maintenance of technical documentation, the CE declaration of conformity, and, where applicable, certificates; retention for 10 years (15 years for implantable products).
Optional: More Than Just the Mandate
Upon request, we can handle more than just the mandatory tasks—e.g., assisting with the conformity assessment in accordance with MDR/IVDR Annexes IX, X, and XI, and serving as the point of contact for the Notified Body during the classification process.
Liability, Mandate, and Termination
The EU authorised representative is jointly and severally liable (Art. 11, (5)); in the event of a breach of duty by the manufacturer, the mandate must be terminated, and the authority and, if applicable, the Notified Body must be informed.
Two scenarios: Medical device (MDR) and IVD (IVDR)
Medical Device – MDR (EU) 2017/745
Authorised representative pursuant to Article 11; manufacturer’s core obligation: clinical evaluation (Article 61), including post-market clinical follow-up. Records must be retained for 10 years, or 15 years for implantable devices, from the date the last product was placed on the market.
IVD – IVDR (EU) 2017/746
Authorised representative pursuant to Art. 11; manufacturer’s core obligation: performance evaluation (Art. 56), including post-market performance follow-up. Records must be retained for 10 years from the date the last product was placed on the market.
Legal Basis, Registers & Guidelines
- MDR (EU) 2017/745 · IVDR (EU) 2017/746 – Art. 11 (Authorised Representative), Art. 12 (Change), Art. 15 (PRRC), MDR Art. 31 / IVDR Art. 28 (Registration), MDR Art. 25 / IVDR Art. 22 (Traceability)
- EUDAMED (Actor/SRN, UDI/Device, Vigilance) + national databases (e.g., DMIDS)
- Certificate of Free Sale (FSC) pursuant to MDR Art. 60 / IVDR Art. 55 upon request · Guideline MDCG 2022-16 (Authorized Representatives)
Swiss Authorised Representative (CH-REP) under MepV/IvDV
The mutual recognition agreement (MRA) on conformity assessment was not renewed; therefore, Switzerland has been considered a third country by the EU for medical devices since May 26, 2021, and for IVDs since May 26, 2022. Since then, foreign manufacturers have been required to appoint a Swiss authorised representative in order to place their products on the market. Metecon provides the CH-REP through Metecon Schweiz GmbH—registered as a Swiss authorised representative (CHRN-AR-20003994).
Registration: swissdamed/CHRN – with deadlines
Initial registration must take place no later than three months after the product is first placed on the market in Switzerland; the Actor Module (module for assigning the CHRN) and swissdamed product registration (UDI Devices module) are responsible for data integrity. Requirement: at least one additional importer registered in Switzerland. Notify Swissmedic of any changes (address, PRRC) within one week.
Appointment & Mandate
Written authorization from the manufacturer; only one CH-REP per generic product group. Provide a copy of the authorization to the authority upon request.
Documents & Deadlines
Technical documentation, the EU declaration of conformity, and certificates must be made available or submitted to Swissmedic within seven days; they must be retained for 10 or 15 years (for implants); they must be provided in one of Switzerland’s official languages.
Feedback & Traceability
Forward complaints and incident reports to the manufacturer; collaborate with importers/distributors to ensure traceability in the supply chain.
Vigilance (Swissmedic)
Reporting of serious incidents, FSCA, and trend reports; submission of final reports; coordination of sample and access requests.
Product Monitoring (PMS)
At the request of a Swiss authority, submission of the periodic safety update report (PSUR), including the assessment results from the Notified Body.
Liability, Mandate, and Termination
The CH-REP is jointly and severally liable along with the manufacturer; if the manufacturer breaches its obligations, the mandate must be terminated, and Swissmedic and the Notified Body must be notified.
Two scenarios: Medical Device (MePV) and IVD (IvDV)
Medical Device – MePV (SR 812.213)
Medical Device – MePV (SR 812.213) — Authorised Representative: MePV Art. 51 → MDR Art. 11; PRRC Art. 52; Record Retention: Art. 48 (10 years; 15 years for implantable devices).
IVD – IvDV (SR 812.219)
IVD – IvDV (SR 812.219) — Authorised Representative: IvDV Art. 44 → IVDR Art. 11; PRRC Art. 45; Retention: Art. 41 (10 years).
swissdamed is separate from EUDAMED—the two databases are maintained independently.
As of July 1, 2026, the registration of medical devices, systems, treatment units, and IVDs in swissdamed is mandatory and replaces the previous reporting requirement.
As of July 1, 2026, the registration of medical devices, systems, treatment units, and IVDs in swissdamed is mandatory and replaces the previous reporting requirement.
Legal Basis & Registers
- MePV SR 812.213 · IvDV SR 812.219 (References to EU MDR/IVDR Articles 10–12, 15)
- swissdamed (product) · CHRN (party, MePV Art. 55, IvDV Art. 48) · Swissmedic as the competent authority
PRRC – Responsible Person in Accordance with Art. 15 MDR/IVDR, Art. 52 MepV, and Art. 45 IvDV
Unlike the EU-REP/EC-REP and CH-REP, the “person responsible for regulatory compliance” (PRRC) is a specific individual role. Both the manufacturer and each authorised representative must have at least one designated PRRC who is available at all times and on an ongoing basis.
Proof of Qualifications (Art. 15, para. 6)
Either a relevant college degree (law, medicine, pharmacy, engineering, or similar) plus at least one year of professional experience in regulatory affairs/quality management—or four years of relevant professional experience.
Availability & Substitute
Permanent and always available; backup must be ensured. If there are multiple PRRCs, their areas of responsibility must be documented in writing.
Scope & Services
Clear distinction between manufacturer PRRC and REP PRRC. Metecon provides the PRRC role or assists in building internal PRRC expertise—any changes must be reported and updated in the registers.
When should you check the PRRC roll?
- When appointing or replacing an authorised representative
- In the event of portfolio or organizational changes
- When entering new target markets
Irina Waal
Expert QM & Regulatory Affairs, PRRC · Metecon GmbHIrina Waal is PRRC and part of the Regulatory Affairs & Technical Documentation team with relevant experience in the manufacturing industry. Irina’s team supports medical devices and IVD manufacturers who require formal representation or PRRC-related assistance. The team ensures that EU-REP/EC-REP, CH-REP, and PRRC roles are not only formally filled but also substantively and reliably managed. Through its sister companies, Metecon Schweiz GmbH and CEyoo GmbH, Metecon offers these services as an integrated part of its structure.
"Having a representative is mandatory, but they only truly demonstrate their value when they actively contribute to regulatory matters and proactively safeguard your market access."
– Expert Quality Management & Regulatory Affairs, PRRC, Metecon GmbH
Frequently Asked Questions
What makes a good EU-REP, EC-REP, or CH-REP?
Availability and prompt response to inquiries from regulatory authorities, accurate registration in EUDAMED/swissdamed, clearly defined responsibilities and escalation procedures, as well as regulatory expertise that goes beyond merely fulfilling mandatory requirements.
How much lead time is needed before the product launch?
Time must be set aside for mandate preparation, registrations (SRN/CHRN, product data), and data maintenance. In particular, the swissdamed registration requirement (effective July 1, 2026) and the EUDAMED registration requirement (effective May 28, 2026) must be observed.
How are EU/EC/CH REPs integrated with PMS, vigilance, and CAPA?
By observing defined information flows and escalation procedures: Who reports what, how, and to whom (regulatory authority, Notified Body), within which timeframe, and how is market feedback incorporated back into the processes?
How do we ensure that technical documentation and registration data remain consistent when changes are made?
By using standardized processes for product/portfolio changes between the manufacturer and the REP: updates in EUDAMED, separate maintenance in swissdamed, and coordination regarding the REP’s reporting obligations.
Which interfaces between REP Service, QMS, and auditing need to be addressed?
Roles, responsibilities, and information flows must be firmly embedded in the QMS in a way that is organizationally robust, so that responsibilities remain clear both in day-to-day operations and during audits.
When should the PRRC role be reviewed, in addition to EU-REP, EC-REP, and CH-REP?
Manufacturers and each authorised representative must have at least one PRRC of their own, in accordance with MDR/IVDR Article 15. The responsibilities of the manufacturer’s PRRC and the authorised representative’s PRRC must be clearly delineated and kept readily available at all times.
What organizational foundations does an EU/EC/CH REP service need?
Designated points of contact, documented responsibilities and deadlines, access to the latest technical documentation, and established processes for record-keeping and reporting.
What factors determine the cost of EU/EC-REP and CH-REP services at Metecon?
Product category and portfolio size, number of target markets (EU and/or Switzerland), volume of changes and vigilance events, and the scope of supplementary regulatory support.
Interfaces & Related Services
An authorised representative only works when processes are properly integrated.
Post-Market Surveillance (PMS)
Ensure that information flows and responsibilities for post-market surveillance data are properly integrated with the REP service.
Vigilance & CAPA
Define and document escalation and reporting procedures.
Technical Documentation
Manage document review and maintenance.
International Registration
Consistently define role/representative setups for each market.
QMS & Auditing
Integrate responsibilities in a way that ensures organizational resilience.
Digitalization
Structured data and consistent information flows.
Designating an Authorised Representatives for the EU and Switzerland
Start with a free initial consultation—we’ll clarify roles (EU-REP/EC-REP, CH-REP, PRRC), registration, and interfaces for your market access.
Your contact:
Dr. Kerris Klug
Sales Manager
T: +49 621 123469-041
kerris.klug@metecon.de
