EU Market Surveillance for Medical Devices and IVDs

Introduction

It might come as a surprise to some but the regulatory environment in Europe concerning medical devices and In Vitro Diagnostic devices (IVDs) is anything but a "set it and forget it". Although the manufacturer is required to conduct Post Market Surveillance (PMS) internally, the EU Market Surveillance system is what makes sure that the products are safe and public health is maintained. This is the final check conducted by national authorities and the one which has revolutionized the way manufacturers conduct themselves in terms of MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), especially due to the recently changing enforcement from a voluntary to a phased mandate platform.

What Market Surveillance Means For You (It's Not Just An Audit)

Market Surveillance is the term which refers to the independent activities conducted by the EU Member State authorities with the purpose of quickly detecting and eliminating non conforming, unsafe, or counterfeit medical devices from the market.

Consider the following picture:

• PMS (Post Market Surveillance): The manufacturer monitors the performance of the device internally (self check).

• Vigilance: The system of reporting serious incidents (reaction to risks).

• Market Surveillance: The EU police, which checks whether the manufacturer is conducting PMS and vigilance properly.

In conclusion, the spotlight is not only on the initial certification of your product but its whole lifecycle on the market.

The Real Impact On Manufacturers: Speed, Integration, And Consequences

For every medical device and IVD manufacturer, the new MDR/IVDR framework puts a number of strict requirements on them and requires faster and more integrated processes. Recent structural and legislative changes sped things up even further:

1. Speed Requirement Becomes Modification

The most significant change here is the shortened timeline for reporting serious incidents (Vigilance). Under the MDR/IVDR, the period of time for reporting serious incidents to the authorities was shortened from 30 days to 15 calendar days from the date of detection. Such a shortened timeline means that the manufacturer must have a fast and documented process for incident classification and reporting in place within its Regulatory, Quality, and R&D teams. Even a few day delay may mean non compliance.

2. EUDAMED Phased Integration & May 2026 Mandate

The European Database on Medical Devices (EUDAMED) is the central database system. With the help of Regulation (EU) 2024/1860, the EU switched to gradual, module by module roll out of this system. After the Commission Decision (EU) 2025/2371 four modules of the EUDAMED became mandatory as of May 28, 2026. They include:

• Actor Registration (requirement for economic operators to obtain Single Registration Number [SRN] before placing devices on the market).

• Unique Device Identification (UDI) and Device Registration (become mandatory for new devices as of May 28, 2026; legacy devices must be registered by November 27, 2026).

• Notified Bodies and Certificates.

• Market Surveillance (ability for Competent Authorities to share inspection reports and non conformities data instantly across the EU).

Manufacturers should be proficient in EUDAMED use. This system allows to see the current situation concerning the safety of the products in real time and transparently to the authorities. Being slow and inaccurate in using the EUDAMED will be easily detected by the authorities in course of market surveillance due to the active Market Surveillance module.

3. Notifications of Supply Interruptions (Required by New Article 10a)

Alongside other new requirements introduced by Regulation (EU) 2024/1860, the provision on obligatory supply interruption notification came into force. Manufacturers should notify the competent authorities, health care establishments, and economic operators no less than six months in advance of any planned interruptions or discontinuation of supply of the device in case this situation might cause significant risks for patients and public health.

4. Non Serious Trends Monitoring & Comprehensive PMS Systems (MDCG 2025 10)

Before, reporting was done only for serious incidents. Nowadays, manufacturers have an obligation to monitor and analyze significant trends in non serious incidents and product malfunctioning. As per the comprehensive MDCG 2025-10 Guidance (published in December 2025), manufacturers need to have a sophisticated PMS system that works closely with the Quality Management System (QMS), risk management, and clinical evaluations. The document provides detailed structures for a PMS plan, where constant data analysis throughout the whole life cycle of the device triggers the CAPA process according to ISO 13485.

5. The Price of Non Compliance Is High

Cooperation with market surveillance authorities is compulsory. If you fail to cooperate or get discovered as non compliant during the inspection, this will lead to the following outcomes:

• Fines and Administrative Penalties.

• Mandatory Product Recalls or Withdrawals.

• Revocation of your CE Certificate.

• Temporary suspension of business operations.

The Regulations

The core regulation for Market Surveillance requirements is the following legislation:

• Article 93 of the Medical Device Regulation (MDR) (EU 2017/745) and Article 88 of the IVD Regulation (IVDR) (EU 2017/746): Defines Market Surveillance and explains what kinds of actions the Competent Authorities (CAs) perform regarding monitoring the market for the devices that are already on the market. Explains the rights of the CAs like requesting documentation, performing announced and unannounced inspections of the manufacturers/suppliers, etc.

• Regulation (EU) 2024/1860: Extends IVDR transitional timelines for certain risk class devices (Class D up to 2027, Class C up to 2028, Class B up to 2029) under strict conditions and a formal agreement with a Notified Body, along with introducing legally mandatory phased implementation of EUDAMED modules.

EUDAMED and Post Market Specific Guidance

Below is the key guidance for manufacturers related to Market Surveillance and EUDAMED:

• EUDAMED User Guide for the Market Surveillance module: Provides the information about what CAs collect and how they use the system to coordinate among different member states.

• MDCG 2025-10 (Guidance on post market surveillance of medical devices and in vitro diagnostic medical devices): Explains how to organize your PMS systems and formulate proactive PMS plans.

• MDCG Guidance on EUDAMED functionality: Collaborates with the Commission Decision (EU) 2025/2371 and governs the transitional upload periods, e.g. 18 months from the end date of May 28, 2027 for Notified Bodies to upload historical certificate metadata.

Conclusion

In order to be compliant with the EU Market Surveillance system, the medical device and IVD manufacturers should apply a very proactive approach. Under the MDR/IVDR and the legally enforced EUDAMED since May 2026, this system of external control makes the manufacturers increase significantly the speed of their reporting (serious incidents should be reported within 15 days from occurrence, supply disruption notifications should be submitted 6 months in advance) and submit transparent data using the mandatory EUDAMED modules. The success depends on the flawless integration of the Post Market Surveillance (PMS) with the Quality Management System (QMS) as per MDCG 2025-10. Otherwise, the failure may cause severe consequences for the company, including product mandatory recall or revocation of the CE certificate.

How Morulaa Can Help

Morulaa specializes in providing help to the global medical device and IVD manufacturers in dealing with the EU regulatory requirements from the CE marking to PMS planning, EUDAMED registration, and post market vigilance. With Morulaa's help, you will stay compliant, audit ready, and confident in your position on the market.