• 2022-08-31 05:37:18

MDCG 2022-12 provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. This guidance intends to describe harmonized administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.

• 2022-08-30 03:21:56

The European Commission has adopted common specifications for several types of high-risk diagnostics, such as HIV tests and SARS-CoV-2 tests. The specifications set uniform and rigorous benchmarks for tests across the EU, clarifying the requirements for market actors and protecting EU patients.

• 2022-07-26 11:06:32

MDCG 2022-8 provides guidance regarding the applicability of IVDR requirements to "legacy devices" and "old" devices. The annex contains a non-exhaustive table illustrating IVDR requirements applicable or not applicable to “legacy devices”.

• 2022-07-26 11:03:38

Five years have passed since the adoption of the MDR. From the end of the transition period, medical devices not certified under the MDR will have no access to the EU market. Thus, it is essential for all manufacturers to apply to a notified body and comply with the MDR as soon as possible.

• 2022-06-29 02:11:11

MDCG 2022-5 is a guidance which provides elaboration of the borderline between medical devices and medicinal products, including relevant definitions and examples for these types of products, such as herbal products, substance-based devices and medical device and medicinal product combinations.

• 2022-02-18 07:20:17

As Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.

• 2022-02-18 09:37:25

The US FDA is planning to issue transition plans for medical devices with Emergency Use Authorizations (EUAs). The EUA measure had previously been implemented in order to increase related necessary medical product supply on the US market.
As the Coronavirus Disease 2019 (COVID-19) pandemic gradually slows down, FDA has published a draft guidance to provide its recommendations to manufacturers, and in order to outline a roadmap for EUA devices to be able to transition after the emergency use declarations are no longer in effect in the future.

• 2021-06-29 11:30:23

On 25th June, Qualtech and ISS AG jointly hosted an enriching webinar session on the newly implemented Medical Device Regulation MDR (EU) 2017/745 (MDR) and the dynamic European medical device landscape. In this article, we are looking at the important points discussed.

• 2021-06-25 12:07:40

The European Medical Device Regulations has been fully enforced starting 26th May 2021, after many delays following the COVID-19 pandemic. It brings forward a set of new standards and requirements which products must comply with, to ensure a high level of public health and patient safety.

• 2021-05-18 01:53:36

Qualtechs will be holding a Webinar focusing on EU MDR on May 25, 2021.

We welcome all interested guests to join for free.