The latest news

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 ...

News, 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...

MDCG documents, MDR, News

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...

MDCG documents, MDR, News

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...

MDR, News

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...

MDCG documents, MDR, MDR, News

EU MDR Bridge

Posted on December 16, 2022 By MDSS

EU MDR Bridge Deadline/transition – further info! What else happened last Friday, next to the proposed extension of the MDR Deadline for legacy products (see our Newsletter from Monday)? The MDCG 2022-18, a very special guidance, was published, intended to guide in particular authorities, to h...

Switzerland

IvDO adopted!

Posted on June 28, 2022 By MDSS

It is confirmed. Switzerland adopted the new Regulation on In-vitro Diagnostics (IvDO), which mainly refers to the IVDR. The provisional text in German language is available here. Now we need to wait for the final version to be published in the Swiss Federal Council website. Once it is published, c...

News

Q & A – new Manufacturer Incident Report (MIR) Form

Posted on May 29, 2020 By mdss

In December 2018, a new Manufacturer Incident Reporting (MIR) form and related documentation have been published at the European Commission website. The form introduced novel information requirements such as use of IMDRF adverse event terms and codes or trending data based on relevant similar in...

News

Exciting developments regarding Harmonized Standards!

Posted on May 21, 2020 By mdss

M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and...

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!

EU MDR Bridge

IvDO adopted!

Q & A – new Manufacturer Incident Report (MIR) Form

Exciting developments regarding Harmonized Standards!

IMPORTANT LINKS

GET IN TOUCH

STAY INFORMED

FOLLOW US ON