MDCG 2021-5 Rev.1 EU REP Symbol Transition Guide

A regulatory guide to the MDCG 2021-5 Rev.1 EU REP symbol transition, mapping OJEU decisions, Swiss and UK representative rules, and QMS timelines.

Executive Summary

What does the new EU REP symbol mean for medical-device and IVD labeling, how long can EC REP and EU REP coexist, and what must manufacturers do before the 2031 deadlines?

The European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the European Union (OJEU) on June 17, 2026, formalizing the replacement of the long-standing EC REP symbol with EU REP for the authorized representative. MDCG 2021-5 Rev.1 (appendix, June 2026) sets a 60-month coexistence period during which manufacturers may use EC REP, EU REP, or both, provided the authorized-representative information stays clear. The old standard reference is withdrawn on June 15, 2031 under the MDR and June 17, 2031 under the IVDR, after which only EU REP confers a presumption of conformity. The change is editorial, no notified-body approval is required, and staggered or over-labeling is explicitly permitted.

What is the EU REP symbol and why is the EC REP symbol being withdrawn?

To understand this transition, one must examine the legal and standardisation history of the European Union. For over three decades, medical devices placed on the European market by non-EU manufacturers have displayed the EC REP symbol (consisting of the letters "EC" and "REP" enclosed within a border) to identify their European Authorized Representative.

The Historical Anachronism of "EC"

The "EC" in the EC REP symbol stands for the European Community. However, the European Community was formally dissolved and succeeded by the European Union on December 1, 2009, with the entry into force of the Treaty of Lisbon. Since then, "EC" has been an obsolete legal descriptor.

Despite the transition to the European Union (EU) and the subsequent implementation of the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), the medical device industry continued to use the EC REP symbol. This was because the harmonized symbol standard, EN ISO 15223-1, still cataloged the symbol under the historical "EC REP" name.

The ISO 15223-1 XX REP Naming Convention

To resolve this discrepancy, the European Commission requested the International Organization for Standardization (ISO) to update the symbol. In March 2025, ISO published an amendment, EN ISO 15223-1:2021/A1:2025, which introduced the general XX REP naming convention:

The "XX" placeholder stands for the specific two-letter country or regional code of the authorized representative.
For the European Union, the symbol becomes EU REP.
For Switzerland, the symbol is CH REP (regulated under Swiss MedDO).
For the United Kingdom, the symbol is UKRP (regulated under MHRA guidelines, though not using the ISO border format).

By updating the standard, the European Commission has aligned medical device labeling with the modern legal reality of the European Union. Manufacturers can review general symbol rules in the ISO 15223 medical device symbols overview.

Old Labeling Standard (Obsolete Legal Basis):
┌───────────┐
│  EC  REP  │  <-- \"EC\" refers to the obsolete European Community
└───────────┘

New Labeling Standard (Harmonized June 2026):
┌───────────┐
│  EU  REP  │  <-- \"EU\" refers to the modern European Union
└───────────┘

What do Implementing Decisions 2026/1231 and 2026/1313 change?

While the ISO amendment was published in 2025, it did not carry a legal "presumption of conformity" in the European Union until the Commission officially harmonized the standard. This harmonization occurred on June 17, 2026, through two Implementing Decisions published in the Official Journal:

Commission Implementing Decision (EU) 2026/1231: Harmonizes the standard EN ISO 15223-1:2021/A1:2025 under the Medical Device Regulation (MDR).
Commission Implementing Decision (EU) 2026/1313: Harmonizes the standard EN ISO 15223-1:2021/A1:2025 under the In Vitro Diagnostic Medical Device Regulation (IVDR).

These implementing decisions do three critical things:

Legal Presumption: They establish that using the new EU REP symbol satisfies the MDR and IVDR requirements to identify the authorized representative on the device label.
Transition Start: They trigger the official 60-month (5-year) coexistence period.
Old Standard Withdrawal: They establish the exact dates when the old standard reference (EN ISO 15223-1:2021 without the amendment) is withdrawn, rendering the EC REP symbol legally obsolete.

How long can EC REP and EU REP coexist, and what are the exact MDR and IVDR deadlines?

The transition period has been designed to prevent market disruption and avoid the unnecessary scrapping of existing packaging and labeling inventory. The European Commission's Medical Device Coordination Group (MDCG) released the MDCG 2021-5 Rev.1 Appendix in June 2026 to outline the transition.

The Coexistence Period

For 60 months starting from the OJEU publication date (June 17, 2026, to June 17, 2031), the EC REP and EU REP symbols are considered coequal. Manufacturers may:

Keep using the EC REP symbol on legacy and newly manufactured devices.
Begin placing the new EU REP symbol on device labeling.
Use both symbols across different product lines or packaging levels, provided the identity of the authorized representative is unambiguous.

The Hard Deadlines

The coexistence period ends abruptly in June 2031, but the exact date differs slightly between the MDR and IVDR due to the specific timelines set in the implementing decisions:

MDR Deadline (Medical Devices): June 15, 2031. Under Implementing Decision 2026/1231, the old standard reference is withdrawn on this date. Devices manufactured or labeled on or after June 16, 2031, must use the EU REP symbol.
IVDR Deadline (In Vitro Diagnostics): June 17, 2031. Under Implementing Decision 2026/1313, the old standard reference is withdrawn on this date. IVD devices manufactured or labeled on or after June 18, 2031, must use the EU REP symbol.

Regulation	OJEU Publication Date	Coexistence Duration	Old Standard Withdrawal Date	Mandated Symbol post-deadline
MDR (EU) 2017/745	June 17, 2026	60 months	June 15, 2031	EU REP
IVDR (EU) 2017/746	June 17, 2026	60 months	June 17, 2031	EU REP

Crucial Distinction: Placed on the Market vs. Manufactured

It is vital to distinguish the date of manufacture/labeling from the date a device is "placed on the market":

Devices labeled with the EC REP symbol and placed on the market before the June 2031 deadlines may continue to be distributed, sold, and used until their expiry dates.
There is no requirement to recall or relabel stock that is already in the commercial supply chain (e.g., in distributor warehouses or hospital inventory) prior to the deadline.
Devices manufactured after the deadline must carry the new EU REP symbol.

Understanding this difference is critical when mapping out global UDI compliance deadlines 2026 and coordinating labeling updates.

EUDAMED Registration and Single Registration Numbers (SRN)

The role of the European Authorized Representative is not merely graphic; it is integrated into the European Union's medical device database, EUDAMED.

The Role of the SRN

Every Authorized Representative must register in the EUDAMED Actors Module to obtain a Single Registration Number (SRN).

The SRN is a unique identifier generated by EUDAMED that confirms the representative's legal identity and verified location.
While the symbol on the physical label changes from EC REP to EU REP, the representative's SRN remains identical (unless the representative changes their legal entity or physically relocates).
Label Requirements: Under EU MDR Annex I, Section 21.1, the name and address of the authorized representative must appear adjacent to the symbol. While the SRN itself is not legally required to appear on the physical label (the address is mandatory), it must match the SRN listed in the device's EUDAMED registration.

Common Registration Gaps

When auditing their representative status during the symbol transition, manufacturers frequently uncover registration errors:

Discrepancies between the address listed on the physical label and the address registered in EUDAMED. Even minor differences (e.g., street abbreviations) can trigger customs delays or audit findings.
Outdated authorized representative agreements that have not been uploaded to EUDAMED.
Failure to update local distributor lists associated with the authorized representative.

Manufacturers should use the symbol transition as an opportunity to review their complete EUDAMED dossier, following the steps in the EUDAMED registration guide.

Swiss and UK Representative Symbols: Navigating Non-EU Borders

Manufacturers exporting devices to multiple European countries must manage the overlapping borders of Switzerland and the United Kingdom, both of which have distinct rules.

1. Switzerland: The CH REP Symbol

Following the collapse of the Swiss-EU Mutual Recognition Agreement (MRA) update, Switzerland operates under its own Medical Devices Ordinance (MedDO).

Non-Swiss manufacturers must designate a Swiss Authorized Representative (CH REP).
The symbol CH REP (using the ISO 15223-1 border style) must be placed on the labeling of devices sold in Switzerland.
Dual Labeling: For products sold in both the EU and Switzerland, the label will typically need to display both the EU REP symbol (with the EU representative's details) and the CH REP symbol (with the Swiss representative's details).

2. United Kingdom: The UKRP Requirements

The UK Medicines and Healthcare products Regulatory Agency (MHRA) requires non-UK manufacturers to appoint a UK Responsible Person (UKRP).

Unlike the EU and Switzerland, the UK has not harmonized a specific graphic symbol (like "UK REP" in a box) for the UKRP.
Instead, manufacturers must print the name and address of the UKRP adjacent to the UKCA mark on the label.
The UK continues to accept the CE mark and EU representative labeling under transition timelines, but dual-market labels must be carefully mapped.

For a detailed analysis of non-EU market access, see the EU authorized representative EC REP guide and Swiss MRA updates.

Quality Management System Change Control (ECO) Checklist

Under ISO 13485:2016 and FDA QSR/QMSR guidelines, any change to a device's labeling must be documented through a formal Engineering Change Order (ECO) or change control process.

Below is the standard change control checklist that quality managers should implement to document the transition:

1. Change Initiation & Description: Record the rationale for the change (i.e., compliance with Implementing Decisions 2026/1231 and 2026/1313 and standard EN ISO 15223-1:2021/A1:2025).
2. SKU & Document Impact Assessment: List all affected SKU numbers, label templates, package cartons, IFUs, and website references.
3. Inventory Disposition Plan: Establish a clear run-down plan for existing label inventory to minimize scrap costs. Decide whether over-labeling (stickers) will be used for transitional stock.
4. Artwork Verification: Verify that the new EU REP graphic symbol matches the proportions specified in the ISO standard. Ensure the representative's name, address, and contact information are correct and adjacent to the symbol.
5. Technical File Update: Add the revised label templates and the change control record to the device's technical file.
6. Notified Body Notification Review: Confirm that the change is editorial and does not require prior Notified Body approval. Note the change for the next surveillance audit.
7. Verification of EUDAMED Alignment: Confirm that the representative address on the new artwork matches the representative's SRN registry details in EUDAMED.
8. Training Records: Train labeling design staff and packaging operators on the new labeling templates and visual inspection criteria.

Label Sticker Validation Protocols (ISO 11607 & ASTM)

If a manufacturer decides to utilize an over-label (sticker) containing the new EU REP symbol to cover the old EC REP symbol on pre-printed packaging, this sticker becomes part of the sterile barrier system or protective packaging. Consequently, it must undergo formal validation testing under ISO 11607-1 (Packaging for terminally sterilized medical devices) and specific ASTM standards.

1. Adhesion Testing (ASTM D3330)

The adhesive backing of the sticker must be verified to ensure it does not peel off during shipping or storage.

Test Method: Peel adhesion testing under ASTM D3330 measures the force required to remove the label from the packaging substrate (carton, Tyvek, or plastic pouch).
Acceptance Criteria: The label must demonstrate sufficient peel force to prevent accidental peeling, and must not leave adhesive residue that compromises sterile barrier handling.

2. Abrasion and Rub Resistance (ASTM D5264)

The printed ink on the sticker must remain legible throughout the device's shelf life, resisting friction during transport.

Test Method: The Sutherland Rub Test (ASTM D5264) subjects the printed label to mechanical rubbing under controlled pressure.
Acceptance Criteria: There must be no visible smearing, fading, or loss of character definition that renders the EU REP symbol or address illegible.

3. Chemical Resistance Testing

Labels on medical devices are frequently exposed to sanitizing agents, especially in clinical environments.

Test Method: The label is exposed to chemical rubs using common clinic agents, including 70% Isopropyl Alcohol (IPA), Bleach (Sodium Hypochlorite), and Hydrogen Peroxide.
Acceptance Criteria: The print must remain completely legible, and the adhesive must not degrade or lift at the edges after exposure.

4. Environmental Conditioning (ASTM D4332)

Before performance testing, label samples must undergo climatic conditioning to simulate shipping and warehouse environments.

Conditioning Profiles: Samples are subjected to high temperature/humidity cycles (e.g., 60°C / 90% RH), sub-zero storage (-20°C), and dry desert conditions to ensure the adhesive does not dry out or fail.

Do manufacturers need notified-body approval to switch to EU REP?

A common point of anxiety for regulatory-affairs teams is whether modifying the authorized representative symbol constitutes a "significant change" that requires prior approval from their Notified Body.

An Editorial Change Only

The MDCG 2021-5 Rev.1 guidance and statements from major Notified Bodies (such as GMED, TÜV SÜD, and BSI) confirm that:

The transition from EC REP to EU REP is classified as an editorial change only.
It does not affect the safety, performance, or design characteristics of the medical device.
It does not alter the actual identity, address, or legal contract of the designated authorized representative.

Notified Body Notification Rules

Because it is an editorial change, no prior approval or submission is required from the Notified Body to initiate the label swap.

QMS Audits: The transition plan and updated label templates should be documented within the manufacturer's Quality Management System (QMS) and made available to the Notified Body during routine surveillance audits.
Technical Documentation: The technical file should be updated at the next natural revision cycle (e.g., during the annual CER or PMS file review).
Certificate Impact: The change does not invalidate existing EC or EU Quality Management System certificates.

However, if a manufacturer is changing their actual authorized representative entity or location (and not just the symbol), this does constitute a significant change that must be registered in EUDAMED and approved by the Notified Body beforehand.

How should manufacturers phase the relabel across existing label stock?

Because the transition window is 60 months, manufacturers should treat this as a cost-optimization project rather than an emergency compliance drill. Scrapping pre-printed cartons, sterile barrier pouches, and instruction manuals is expensive. A phased transition plan is the standard industry approach.

Phase 1: Impact Assessment and Inventory Mapping (Months 1–6)

Identify all active SKU families: Map out which SKUs are exported to the European Union and require the symbol update.
Audit current label stock: Record the quantity and value of pre-printed packaging materials, sterile bags, and printed instructions for use (IFUs) currently in inventory.
Identify natural update cycles: Determine which products are scheduled for artwork refreshes, clinical evaluations, or UDI updates over the next three years.

Phase 2: QMS Integration and Procedure Updates (Months 6–12)

Issue a Change Order (CO): Document the transition project in the QMS under a formal change control record.
Update standard operating procedures (SOPs): Revise the labeling design guidelines and QMS template catalogs to include the new EU REP symbol.
Validate the symbol artwork: Ensure the EU REP graphic matches the dimensions and proportions specified in EN ISO 15223-1:2021/A1:2025.

Phase 3: Staggered Artwork Rollout (Months 12–48)

Apply to new products first: Ensure any new device seeking CE mark under MDR or IVDR utilizes the EU REP symbol from day one.
Sequence existing products: Roll out updated labeling to existing product lines during scheduled artwork reviews, packaging changes, or when pre-printed stock levels reach reorder points.
Use over-labeling if necessary: For high-value pre-printed packaging, qualify an over-label (sticker) containing the EU REP symbol. This is explicitly permitted under MDCG 2021-5 Rev.1, provided the adhesive is validated for the device's shelf life and storage conditions.

Phase 4: Final Verification and Compliance Gate (Months 48–60)

Audit remaining SKUs: Conduct a final reconciliation review 12 months before the 2031 deadline to identify any slow-moving products that have not yet transitioned.
Mandatory Cutoff: Implement a hard cutoff in production lines to ensure no devices are manufactured with the old EC REP symbol after June 15, 2031 (MDR) and June 17, 2031 (IVDR).

MANUFACTURER PHASING TIMELINE (2026 - 2031)

2026 (June) — OJEU Harmonization (Implementing Decisions 2026/1231 & 2026/1313)
  │
  ├─ Phase 1: SKU Impact Assessment & Label Stock Inventory Audit
  │
2027 ── Phase 2: QMS Integration, SOP updates, and Change Order initiation
  │
  ├─ Phase 3: Staggered rollout: Apply EU REP during natural artwork refreshes
  │           and deplete existing pre-printed label stock
  │
2030 ── Phase 4: Final verification audit of remaining SKUs; initiate over-labeling
  │              for slow-moving inventory lines
  │
2031 (June) ── Hard Compliance Gate (MDR: June 15 / IVDR: June 17)
              Only EU REP permitted for new production.

Frequently Asked Questions (FAQs)

When does the EC REP symbol stop being valid in the EU?

The EC REP symbol stops conferring a presumption of conformity on June 15, 2031 for medical devices regulated under the MDR, and on June 17, 2031 for in vitro diagnostics regulated under the IVDR. After these dates, new production must carry the EU REP symbol.

Is the EC REP to EU REP change a safety or only an editorial change?

The transition is classified as an editorial change. It has no impact on device safety, performance, or clinical utility, and does not change the actual identity of the authorized representative. Consequently, it does not require prior approval from a Notified Body.

Can a manufacturer show both EC REP and EU REP symbols during the transition?

Yes, during the 60-month coexistence period (June 2026 to June 2031), manufacturers may use either symbol or both across different packaging levels and product lines, as long as the authorized representative information remains clear, legible, and correct.

Do Swiss authorized representatives use a different symbol?

Yes, Swiss authorized representatives must be identified using the CH REP symbol, which utilizes the same ISO 15223-1 border format but with the "CH" country code for Switzerland. This is required under Swiss MedDO regulations.

What are the validation requirements for over-labeling during the transition?

If a manufacturer chooses to apply a sticker containing the EU REP symbol over old packaging, they must validate the adhesive force (ASTM D3330), printing rub resistance (ASTM D5264), chemical sanitization rub resistance, and climatic conditioning (ASTM D4332) to ensure the sticker remains adhered and legible over the device's shelf life.

Regulatory Compliance and Disclaimers

This compliance guide is provided for educational and administrative purposes only and should not be construed as legal advice or formal regulatory consultation. Manufacturers must verify their labeling plans against the latest official text of Commission Implementing Decisions 2026/1231 and 2026/1313, MDCG 2021-5 Rev.1, and consult with their designated European Authorized Representative and Notified Body.