The latest news

Important Updates on EUDAMED and Economic Operator Responsibilities!

Posted on November 3, 2023 By MDSS

The European Commission released some updates regarding EUDAMED, the European Database on Medical Devices. These updates pertain to the responsibilities of economic operators. The update on the EUDAMED – release notes, section 2.1, reflects Article 31 §5 from MDR (EU) 2017/745 and Article 28 ...

News, Switzerland

Revision of MedDO and IVDO

Posted on October 13, 2023 By MDSS

New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices. The Federal Council of Switzerland has decided to amend the Medical Devices Ordinance (MedDO) in alignment with EU requireme...

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Manual on borderline and classification for medical devices under MDR & IVDR!

Posted on October 4, 2023 By MDSS

A new version was just published. This manual serves as a valuable resource for understanding classification rules and define whether your product qualifies as a medical device. In case you encounter a classification disagreement and seek illustrative examples, this manual is your go-to resource. T...

News, UK

Advantages of conducting business in the UK. Possible under the MDR?

Posted on September 27, 2023 By MDSS

There are potential advantages of conducting business in the UK. The pressing question is: Can this also be achieved within the framework of the Medical Device Regulation (MDR)? In instances where a virtual manufacturer lacks product design rights, both the UK Approved Body/EU Notified Body and the...

MDR, News

Flowchart for determining eligibility under the extended MDR transitional period for Devices

Posted on September 6, 2023 By MDSS

The Commission just published a Flowchart to assist manufacturers and stakeholders in determining device coverage under the extended transitional period of the MDR. The purpose of the flowchart is to aid manufacturers and other relevant stakeholders in making a determination about the inclusion of ...

News, Switzerland

Swiss Database on Medical Devices – swissdamed!

Posted on August 24, 2023 By MDSS

Swissmedic released a comprehensive guidance document for the implementation of the Swiss Database on Medical Devices – swissdamed. Feel fully prepared by checking it out on the Swissmedic website or downloading it here! This decision is in line with the regulatory frameworks outlined in the...

MDR, News, UK

Important Announcement: CE-Marking Extensions and Medical Devices in the UK

Posted on August 2, 2023 By MDSS

The UK Government has made a significant announcement concerning CE-marking extensions, and we want to ensure absolute clarity on the matter. However, before jumping to conclusions, let’s get the facts straight. Please take note: This extension DOES NOT include Medical Devices or In Vitro Diag...

MDR, News

Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers

Posted on August 2, 2023 By MDSS

Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers We have some fantastic news for all medical device manufacturers out there! The European Commission has just released the results of a recent survey that sheds light on the progress of the Medical Device Regu...

MDR, News, UK

Timelines for CE Marked Medical Device Placement in the Great Britain Market: UK MDR 2023 Update

Posted on June 20, 2023 By MDSS

UK MDR Update published! It is finally official! The Medical Devices (Amendment) (Great Britain) Regulations 2023 – statutory instrument 2023 No. 677 will come into force on July 1, 2023. You can find the legal text on this link. The UK government has extended the acceptance of CE marked medic...

News, UK

New timelines for CE marked medical devices to continue to be placed on the Great Britain market!

Posted on May 2, 2023 By MDSS

The UK government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023! Subject to Parliamentary approval, the UK plan is to to introduce legislation before 30 June 2023, which will establish new significant timelines for CE marked medical devices to continue to be ...

Important Updates on EUDAMED and Economic Operator Responsibilities!

Revision of MedDO and IVDO

Manual on borderline and classification for medical devices under MDR & IVDR!

Advantages of conducting business in the UK. Possible under the MDR?

Flowchart for determining eligibility under the extended MDR transitional period for Devices

Swiss Database on Medical Devices – swissdamed!

Important Announcement: CE-Marking Extensions and Medical Devices in the UK

Exciting Trends in MDR/IVDR Transition: A Promising Update for Medical Device Manufacturers

Timelines for CE Marked Medical Device Placement in the Great Britain Market: UK MDR 2023 Update

New timelines for CE marked medical devices to continue to be placed on the Great Britain market!

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