Extension of the MDR for legacy devices!

Posted on March 3, 2023 By MDSS

On February 16, 2023, the European Parliament adopted the extension of the transition period for the EU MDR and to extend the validity of certain device certificates (here is MDSS’ outline on the proposal extension and on Article 97). See how Switzerland and the UK reacted in their official ...

News, MDR

New Features and Improvements in EUDAMED

Posted on February 24, 2023 By MDSS

EUDAMED Production v 2.10 has been released with several new features and improvements. Are you ready for the latest and greatest version of EUDAMED Production? Look no further than version 2.10, which comes with a range of exciting new features and improvements. In this post, we’ll provide yo...

News, MDCG documents, MDR

Key Terms in the Medical Device Regulation

Posted on February 16, 2023 By MDSS

Key Terms and Concepts in the Medical Device Regulation – Vigilance The vigilance requirements under the EU’s medical device regulations can be complex and confusing. To help you navigate this landscape, the Medical Device Coordination Group (MDCG) has released a guide to key terms and c...

News, MDCG documents

MDCG Guidance Document on IVD classification

Posted on February 15, 2023 By MDSS

MDCG guidance document on IVD classification If you’re involved in the manufacture or sale of in vitro diagnostic medical devices (IVDs) in the European Union, you’ll want to familiarize yourself with the MDCG guidance document on IVD classification. This document (second revision), deve...

News, MDR

Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation

Posted on January 31, 2023 By MDSS

Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation The EU’s Medical Device Regulation (MDR) has brought new requirements for the conformity assessment of high-risk medical devices. This regulation includes the implementation of the Clinical Evaluation ...

MDCG documents, MDR, Switzerland

Handling of Certification Gaps according to MDCG 2022-18

Posted on January 25, 2023 By MDSS

Handling of Certification Gaps according to MDCG 2022-18 Introduction The Medical Device Coordination Group (MDCG) has released a new document that provides guidance on handling certification gaps for medical devices in the EU/EEA. The document, MDCG 2022-18, addresses the procedures for handling ce...

News, MDCG documents, MDR

Standard Fees for Notified Bodies under MDR and IVDR

Posted on January 25, 2023 By MDSS

Standard Fees for Notified Bodies under MDR and IVDR The Medical Device Coordination Group (MDCG) has released a new document, MDCG 2023-2 This document, endorsed by the Medical Device Coordination Group (MDCG), outlines the standard fees for conformity assessment activities carried out by notified ...

MDCG documents, MDR, News

Proposal for amending the medical devices transition extension was published!

Posted on January 9, 2023 By MDSS

The proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was adopted on January 6, 2023 by the Commission. The Parliament...

News, MDCG documents, MDR

The MDCG Position Paper On The Temporary Use Of Article 97 Of The MDR

Posted on January 5, 2023 By MDSS

Article 97 – Expiring medical device certificates (Temporary application of Article 97 MDR) The Medical Devices Coordination Group’s (MDCG) position paper on the temporary application of Article 97 MDR of the MDR addresses a specific issue facing the medical device industry: how to handl...

News, MDR

Products without an intended medical purpose!

Posted on December 19, 2022 By MDSS

Products without an intended medical purpose! The regulation (EU) 2022/2346, released on 1 December 2022, lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745. The transitional provision are explained in Articl...

Extension of the MDR for legacy devices!

New Features and Improvements in EUDAMED

Key Terms in the Medical Device Regulation

MDCG Guidance Document on IVD classification

Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation

Handling of Certification Gaps according to MDCG 2022-18

Standard Fees for Notified Bodies under MDR and IVDR

Proposal for amending the medical devices transition extension was published!

The MDCG Position Paper On The Temporary Use Of Article 97 Of The MDR

Products without an intended medical purpose!

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