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MedNet EC-REP at MEDICA 2026 in Düsseldorf
From 16 to 19 November 2026, MedNet EC-REP will be at MEDICA in Düsseldorf – join us at Hall 17, Stand E05.
MedNet EC-REP
MEDICATrade fair
News & Regulatory Updates
Stay informed about the latest regulatory requirements, industry developments, and expert insights from MedNet EC-REP
Updated regularly
41 Articles
Guides
The Most Common Mistakes in Initial EUDAMED Actor Registration and How to Avoid Them
EUDAMED Actor Registration is now mandatory for every manufacturer placing devices on the EU market. Here are the five mistakes we see most often during initial registration and how to avoid the delays they cause.
MedNet EC-REP
EUDAMEDActor RegistrationUDI/Device Registration
Regulatory Updates
MHRA Consultation 2026: The Fee Increases Coming for Medical Device Manufacturers in 2027
The MHRA has opened a consultation on fee increases from April 2027 — including a proposed 70 % rise in the post-market surveillance fee. Manufacturers have until 25 September to respond.
MedNet EC-REP
MHRAUK Responsible Person
Guides
What Is an EU Authorized Representative? The 5 Key Questions for Manufacturers Outside the EU
Do you need an EU Authorized Representative? Learn who needs one, their obligations, liability, and how they differ from importers and distributors.
MedNet EC-REP
EU-REPMDR/IVDR
Guides
Device Registration Transition Deadline, 28 November 2026: What Manufacturers Need to Do Now
Legacy and Regulation devices under transition must be registered in EUDAMED by 28 Nov. 2026. Learn who's affected, how EUDAMED-DI/ID registration works, and how to avoid mistakes.
MedNet EC-REP
EUDAMEDMDRIVDR
Guides
PPWR Quick Guide: EU PPWR Compliance Steps for Medical Device and IVD Manufacturers
The EU PPWR applies from 12 August 2026, no grace period. See the compliance steps medical device and IVD manufacturers need now. Read the guide.
MedNet EC-REP
EU PPWREPR RepresentativeMedical Device+1 more
Regulatory Updates
New EU Study: Where Manufacturers and Authorised Representatives Really Stand on MDR and IVDR
New EU study finds 48% of manufacturers have withdrawn devices from the market. Key MDR/IVDR and AR findings for 2026. Read the numbers now.
MedNet EC-REP
MDRIVDREU Study+1 more
Regulatory Updates
Well-Established Technologies Under the MDR: EU Commission Expands Exemption List
The EU Commission has expanded the WET list under the MDR, easing requirements for certain class II and class III devices.
MedNet EC-REP
MDRWETMDCG 2020-6
Regulatory Updates
MHRA Device Registration: New Clarification on "Placing on the Market" and "Putting into Service" (Update 20 July 2026)
MHRA clarifies medical device registration: 20 July 2026 update explains "placing on the market" vs. "putting into service" in GB.
MedNet EC-REP
MHRAUK MDR
Regulatory Updates
EC REP Becomes EU REP: What the New Authorised Representative Symbol Means for Medical Device Manufacturers
In short: On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European Union (OJEU) for both the MDR and the IVDR. This amendment replaces the long-standing "EC REP" symbol with "EU REP" for the authorised representative in the European Union. The change is purely editorial, and you have a five-year transition period - until 17 June 2031 - during which both symbols remain valid.
MedNet EC-REP
EU-REPEC-REPMDR+1 more
Regulatory Updates
New swissdamed registration fees - what manufacturers need to know from 2027
From 1 July 2026, all medical devices placed on the Swiss market must be registered in the national swissdamed database. Together with this registration obligation, the Swiss Federal Council has approved a revised Swissmedic fee ordinance introducing a product registration fee. The first invoices will be issued in January 2027. Here is what to expect.
MedNet EC-REP
MedDOIvDOSwissdamed+1 more
Regulatory Updates
EU Expands eIFU Eligibility: Key Changes under Implementing Regulation (EU) 2025/1234
The EU expands the use of electronic Instructions for Use (eIFU) for professional-use medical devices under Implementing Regulation (EU) 2025/1234. Key compliance considerations for MDR and IVDR manufacturers.
MedNet EC-REP
MDRIVDReIFU