Question 1

What is Swissmedic and why is it important for medical device manufacturers?

Accepted Answer

Swissmedic is the Swiss national authority responsible for the authorization and supervision of therapeutic products, including medical devices. Following the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), Switzerland updated its Medical Devices Ordinance (MedDO) to align with EU requirements while maintaining its own sovereign regulatory system. Swissmedic oversees device registration, conformity assessment recognition, market surveillance, and post-market vigilance. Manufacturers must designate a Swiss Authorized Representative and comply with MedDO requirements to access the Swiss market.

Question 2

What is the MedDO and how does it relate to EU MDR/IVDR?

Accepted Answer

The Medical Devices Ordinance (MedDO, in German: Medizinprodukteverordnung - MepV) is Switzerland's primary regulation for medical devices, which came into force on May 26, 2021, aligning with EU MDR timelines. Key Alignments with EU MDR/IVDR: Similar risk-based classification (Class I, IIa, IIb, III), equivalent conformity assessment procedures, technical documentation requirements mirror EU MDR Annexes, UDI system implementation, post-market surveillance and vigilance obligations. Key Differences: Separate Swiss conformity assessment bodies (not EU Notified Bodies), Swiss Authorized Representative required (not EU Rep), registration with Swissmedic (not EUDAMED). The MedDO ensures close alignment to facilitate trade while maintaining Swiss sovereignty.

Question 3

What is the Mutual Recognition Agreement (MRA) and how does it affect medical devices?

Accepted Answer

The Switzerland-EU Mutual Recognition Agreement (MRA) historically allowed for mutual recognition of conformity assessments between Switzerland and the EU. Important Update (2024): The MRA for medical devices was adapted following Switzerland's adoption of MDR/IVDR-aligned regulations. Under the updated framework: Limited Mutual Recognition: Swiss conformity assessment bodies can be recognized for certain procedures, Separate Certifications Still Required: CE marking for EU, Swiss-specific marking/registration for Switzerland, Close Monitoring Needed: MRA status subject to ongoing EU-Switzerland negotiations. Manufacturers should verify current MRA provisions and may need dual strategies for EU and Swiss markets.

Question 4

What is a Swiss Authorized Representative and who needs one?

Accepted Answer

A Swiss Authorized Representative (also called Swiss Representative or Swiss Agent) is a natural or legal person established in Switzerland designated by a non-Swiss manufacturer to act on their behalf with Swissmedic. Requirements: Must be domiciled in Switzerland, registered with Swissmedic, Responsibilities: Register devices with Swissmedic, maintain technical documentation and declarations of conformity, serve as point of contact for Swissmedic, handle post-market surveillance and vigilance reporting, coordinate with manufacturers on safety issues. A Swiss Authorized Representative is mandatory for all non-Swiss manufacturers (including EU manufacturers) placing medical devices on the Swiss market.

Question 5

How does Swiss medical device classification work?

Accepted Answer

Switzerland uses a risk-based classification system aligned with EU MDR: Class I: Low risk (e.g., non-invasive devices, surgical instruments), Class IIa: Medium risk (e.g., short-term invasive devices, some diagnostic devices), Class IIb: Medium-high risk (e.g., long-term invasive devices, contraceptive devices), Class III: High risk (e.g., implantable devices, devices with medicinal substances). Classification rules follow EU MDR Annex VIII, considering factors like invasiveness, duration of use, whether the device is active, and intended purpose. Higher class devices require third-party conformity assessment by Swiss-recognized bodies.

Question 6

What are the Swissmedic registration requirements for medical devices?

Accepted Answer

All medical devices placed on the Swiss market must be registered with Swissmedic: Manufacturer Registration: Manufacturers (or their Swiss Authorized Representatives) must register with Swissmedic, Device Registration: Each device or device family must be registered before commercialization, Required Information: Device classification, intended purpose, technical specifications, conformity certificates (for Class IIa/IIb/III), UDI information, labeling and instructions for use. Timelines: Registration processed by Swissmedic (usually 2-4 weeks for complete applications). Annual Updates: Registration information must be kept current, changes reported promptly.

Question 7

How often is Swissmedic regulatory news updated and how can I stay informed?

Accepted Answer

Swissmedic regularly publishes guidance documents, ordinances, safety alerts, and policy updates related to medical device regulation and MRA developments. Our platform aggregates daily updates from 7 premium commercial sources including RAPS, Emergo by UL, Citeline, and Pacific Bridge Medical. We recommend checking this page regularly and subscribing to Swissmedic's newsletter for critical safety information and regulatory changes affecting Swiss market access.

Question 8

What commercial sources does this platform use for Switzerland news?

Accepted Answer

We aggregate Swiss regulatory intelligence from 7 premium sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Pacific Bridge Medical, Asia Actual, Pure Global's proprietary research, and Qualtechs. These sources provide expert analysis, real-time updates, and strategic insights beyond basic Swissmedic announcements, helping you navigate MedDO compliance, Swiss Representative designation, MRA implications, and dual Swiss-EU regulatory strategies.

Switzerland Swissmedic Medical Device News 2025: MedDO & Regulatory Updates | Pure Global

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