QNET Newsletter – October 2025
Introduction
Rules for placing medical devices, IVDs, and other regulated products on the market are changing fast. New EU regulations, adjustments in the UK and Switzerland, and global initiatives such as IMDRF and MDSAP are reshaping how manufacturers can sell their products worldwide.
This newsletter highlights the most relevant updates to help you understand what is happening, why it matters, and how QNET can support you as your EU Authorized Representative (EAR), UK Responsible Person (UKRP), Swiss Representative (CH-REP), and US Agent.
EU – Broader Responsibilities under the GPSR
Until now, appointing an EU Authorized Representative (EAR) was primarily a requirement for CE-marked medical devices and IVDs. From 13 December 2024, this will expand due to the General Product Safety Regulation (EU) 2023/988 – GPSR.
What this means:
Every manufacturer located outside the EU that sells non-food consumer products in the EU must appoint an EU Responsible Person (EURP). The goal is to ensure that every product sold in the EU has a clearly identifiable party inside the EU who is accountable for safety, traceability, and incident handling.
For medical devices, the MDR/IVDR rules remain in place; the GPSR requirement comes in addition to them.
If your company does not yet have a EURP or EAR, it’s time to act now.
Stronger Duties for the EU Authorized Representative
The MDCG guidance 2022-16 clarified that an EAR is not merely an administrative contact but is legally responsible for compliance.
Key points:
- An EAR may be held liable if a non-EU manufacturer fails to meet regulatory obligations.
- Every EAR must have a PRRC (Person Responsible for Regulatory Compliance) available to oversee MDR/IVDR compliance.
- When changing EARs, the handover must be documented carefully, including updates to labels and Declarations of Conformity.
QNET has an in-house, registered PRRC to ensure continuous compliance and regulatory support.
United Kingdom – Transition to UKCA with UKRP Support
Since Brexit, the UK has introduced its own product marking, known as UKCA.
While CE-marked devices are still accepted for now, the government has confirmed that UKCA will become mandatory for medical devices from 30 June 2028 (and for IVDs from 30 June 2030).
What this means:
- Manufacturers marketing products in the UK will face a dual route: CE for the EU and UKCA for the UK.
- Non-UK manufacturers must appoint a UK Responsible Person (UKRP) to manage registrations and communication with the MHRA.
QNET Ltd, office based in England, UK, provides full UKRP services and supports companies in preparing for UKCA labelling and registration well ahead of the deadlines.
Switzerland – CH-REP Remains Essential
As long as the Mutual Recognition Agreement (MRA) between the EU and Switzerland is not renewed, non-Swiss manufacturers must appoint a Swiss Representative (CH-REP).
The CH-REP:
- acts as the official contact point for Swissmedic,
- ensures that technical documentation is available in Switzerland,
- manages vigilance reporting and recalls.
QNET CH-REP GmbH is fully equipped to fulfill these statutory duties and can also manage the upcoming Swissmedic registration requirements.
United States – The Ongoing Need for a US Agent
For all non-US manufacturers placing medical devices on the US market, appointing a US Agent registered with the FDA remains mandatory. The US Agent serves as the primary point of contact for the FDA during inspections, safety inquiries, and any potential product recalls.
QNET LLC provides a US Agent service integrated with our EAR, UKRP, and CH-REP offerings — giving you one reliable partner across all major markets.
International Developments: IMDRF & MDSAP
The International Medical Device Regulators Forum (IMDRF) is playing an increasingly important role in harmonising global rules. On 4 September 2025, the MDCG’s International Matters Working Group reported several key updates:
- Adverse Events Terminology (AET) – updated global codes for incident reporting; training materials and an online test are planned for January 2026.
- Good Regulatory Review Practice (GRRP) – guidance to help regulators rely more on each other’s assessments (regulatory reliance), aiming to shorten market-authorisation timelines.
- Software as a Medical Device (SaMD) – efforts to align with the EU’s AI Act; particularly relevant for software-driven devices.
- Quality Management Systems (QMS) – post-COVID revisions focusing on CAPA and supply-chain robustness.
- Clinical Evidence for IVDs – a new guidance document is scheduled for public consultation in January 2026.
- AI / Machine Learning – still at an early stage but becoming a strategic priority for future international standards.
There is also growing pressure from MedTech Europe and some national regulators to encourage the EU to recognise MDSAP audit reports. Currently, 15 Notified Bodies participate in MDSAP. Recognition of MDSAP results could eventually reduce duplicate audits for manufacturers operating globally.
Why this matters to you:
Companies developing SaMD, AI-enabled devices, or IVDs should anticipate new international guidance over the next few years. Manufacturers who already hold MDSAP certification may benefit from reduced audit burdens in the future.
Emerging Opportunities in New Markets
Several new countries and regions are engaging with the IMDRF as observers or members, including Taiwan, Colombia, Indonesia, Ghana, and the Philippines. Many of these jurisdictions are introducing or considering reliance policies, meaning they may begin to recognise approvals or QMS certificates issued in the EU, US, or Japan. This trend can accelerate market entry for manufacturers once formalized.
Practical Next Steps
- Assess whether your products fall under the new GPSR requirement and appoint an EURP or EAR if needed.
- Start preparations for the UKCA deadlines (2028/2030) well in advance.
- Maintain Swiss market access by appointing a CH-REP.
- Consider MDSAP certification to leverage potential recognition and reduce audit duplication.
- For SaMD, AI-based, or IVD products, monitor upcoming IMDRF guidance and plan for potential new documentation requirements.
With QNET, you gain a single partner for EAR/EURP, UKRP, CH-REP, and US Agent services, simplifying compliance and ensuring uninterrupted global market access.
Final Note
Global regulatory requirements are complex and constantly evolving. QNET’s mission is to translate these changes into clear guidance and actionable steps for your business — keeping you compliant, competitive, and market-ready.
QNET – Your trusted global partner for compliant and secure market access.