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SGS Germany GmbH – Certification Body
SGS Certification Bodies
SGS has several certification bodies according to the European Directives.
News
News
Do you want to have your medical device tested and certified according to MDR and don’t want to be slowed down by long waiting times? Or are you, as a manufacturer of medical devices, considering changing your Notified Body?
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?
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: View publication.
We are happy to announce that the Notified Body SGS Fimko (CE0598) has issued an MDR certificate for its first client in Germany.
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.
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).
On January 6, 2023, the EU Commission adopted a proposal to allow more time to certify medical devices according to Regulation (EU) 2017/745. This decision is aimed at mitigation of the risk of medical devices’ shortages. For many manufacturers the news came as a big relief. Also, for some notified bodies struggling with the overflow of applications it was positive news.
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.”
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 XVI of 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. The deadline for adoption of the standards by the manufacturers is set for May 27, 2024.