MDR

Deadline Alert: Submission Requirements for MDR Conformity Assessment

We're pleased to provide you with important updates regarding the extended transition period for certain medical devices under Regulation (EU) 2023/607. As the landscape of medical device regulations continues to evolve, it's crucial for stakeholders to remain informed and compliant.

In 2023, the European Union introduced Regulation (EU) 2023/607, which extends the transitional provisions for specific medical devices. This extension is accompanied by detailed conditions outlined in Articles 120(2) and (3) of the current version of the Medical Device Regulation (MDR). For a comprehensive understanding, we encourage you to consult the official documents linked below this article.

One of the critical conditions mandates the submission of a formal application for an MDR conformity assessment to the Notified Body by May 26, 2024 (as per Article120(3C (e)) of MDR). For those who have not yet taken action, we stress the urgency of meeting this deadline to ensure compliance.

Latest news

EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know

EU eIFU Regulation Update Draft: What Medical Device Professionals Need to Know

The European Commission has introduced a significant amendment to Implementing Regulation (EU) 2021/2226, impacting how medical device manufacturers provide instructions for use (IFU).

Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6

Understanding the Interplay: MDR, IVDR, and the AI Act – Key Insights from MDCG 2025-6

Recently, the MDCG, in conjunction with the Joint Artificial Intelligence Board (AIB), released the MDCG 2025-6 FAQ document, offering essential clarifications on the interplay between the MDR, the IVDR, and the Artificial Intelligence Act (AIA).

Navigating IVDR and MDR Performance Studies: Key Insights from MDCG 2025-5 Q&A

Navigating IVDR and MDR Performance Studies: Key Insights from MDCG 2025-5 Q&A

The European Medical Device Coordination Group (MDCG) has released its latest guidance, MDCG 2025-5, a comprehensive Questions & Answers document addressing performance studies for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR).

MDCG 2019-11 Rev.1: Important Changes for Medical Device Software Developers

MDCG 2019-11 Rev.1: Important Changes for Medical Device Software Developers

In the dynamic world of medical device regulation, staying abreast of the latest guidance is paramount for manufacturers. The Medical Device Coordination Group (MDCG) has recently released a significant update to its MDCG 2019-11 guidance document, now designated as MDCG 2019-11 Rev.1.

MDCG 2025-4: Key Guidance for Medical Device Software on Online Platforms

MDCG 2025-4: Key Guidance for Medical Device Software on Online Platforms

The European Commission's Medical Device Coordination Group (MDCG) has released the MDCG 2025-4 guidance document, titled "Guidance on the safe making available of medical device software (MDSW) apps on online platforms."

New MIR Form 7.3.1: Key Update for Incident Reporting under EU MDR

New MIR Form 7.3.1: Key Update for Incident Reporting under EU MDR

The European Commission has released a new version of the Manufacturer Incident Report (MIR) form which will become mandatory for all medical device manufacturers from November 2025.

EUDAMED Workshop: Essential Training for Medical Device Stakeholders

EUDAMED Workshop: Essential Training for Medical Device Stakeholders

The European Commission is hosting a free, hybrid EUDAMED workshop in Stuttgart on May 21, 2025, designed to support the onboarding of all actors involved with the European Database on Medical Devices (EUDAMED).

EU Expands Harmonised Standards for MDR: Focus on Medical Gloves, Sterilisation, and Patient Transport Equipment

EU Expands Harmonised Standards for MDR: Focus on Medical Gloves, Sterilisation, and Patient Transport Equipment

The European Commission has taken a significant step in strengthening the regulatory framework for medical devices by harmonising additional standards under the MDR.