News

14.09.2023 | MDR Medical Device Certification with SGS – Meet us at Medica

Do you want to have your medical device certified according to MDR and don’t want to be slowed down by long waiting times? Or as a medical device manufacturer, are you considering changing your Notified Body? More.

_____

28.04.2023 | New IMDRF publication: Guidance on Medical Device Regulatory Review Report contents 

International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators around the world, established in 2011, and builds on the foundational work of the Global Harmonization Task Force (GHTF). More.

_____

30.03.2023 | New guidance document published on the implementation of the vigilance requirements of the Medical Devices Regulation (EU) 2017/745

The Medical Device Coordination Group (MDCG) has published a new guidance document MDCG 2023-3 entitled “Questions and answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices.” More.

_____

03.03.2023 | Update: list of harmonized standards under Medical Device Regulation (MDR)

The list of harmonized standards under Medical Device Regulation (EU) 2017/745 was amended with the latest normative documents concerning respiratory devices and sterile medical products. More.

_____

24.02.2023 | Update of Quality System Regulation with Requirements of ISO 13485:2016

The United States General Services Administration has recently announced that the FDA will update the existing Quality System Regulation for medical devices with the requirements of ISO 13485:2016. More.

_____

23.02.2023 | Disclosure of Standard Fees of Notified Bodies

The Medical Device Coordination Group (MDCG) recommends all MDR Notified Bodies to disclose their list of standard fees. “They should be directly and easily accessible on the website of the Notified Body without any additional steps,” says the new MDCG 2023-2 publication. More.

_____

03.02.2023 | The deadline for MDR certification has been extended: what’s next?

On January 6, 2023, the EU Commission adopted a proposal to allow more time to certify medical devices according to Regulation (EU) 2017/745. More.

_____

27.01.2023 | Devices without medical intended purpose according to MDR (EU) 2017/745 Annex XVI

The European Commission has published two new documents, which detail the rules on EU market access for manufacturers of devices without medical intended purpose listed in Annex XIV of MDR. More.

_____

27.10.2022 | SGS AT MEDICA 2022 IN DUSSELDORF / GERMANY (NOVEMBER 14 - 17)

At the world’s largest event for the medical industry, the experts from SGS – the world market leader in the field of testing, inspection, and certification – will inform you about how to successfully place your medical devices on the international market and which standards and regulations you must comply with. More.

_____

10.06.2022 | IEC 62368-1 Global Implementation Overview

Since the IEC 62368-1 standard “Audio/video, information, and communication technology equipment – Part 1: Safety requirements” came into effect, more and more countries or regions have transitioned, or are in the process of transitioning, to IEC 62368-1 standard. Please find the analyzation on safety certification from our SGS experts. More.