Do manufacturers need to re-assess their products when new regulations come into force?

Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment. The conformity assessment usually ... Mar 2, 2021 ... The FDA approval and CE-marking of Guardant360 CDx for tumor mutation profiling and as a companion diagnostic for Tagrisso (osimertinib) ... CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services. All shoes or boots marked CE guarantee a high level of comfort and durability established on the basis of the following standards. Jul 28, 2022 ... Which medical devices require a CE mark? All medical devices sold in the EU require a CE mark. While a CE mark is not required for items such as ... 360 Compliance is here to offer expert guidance and support through every step of the certification process, ensuring a smooth market entry. Mar 21, 2024 ... By using the Vitrolife CE marked medical devices, healthcare providers and patients can have greater confidence that the devices meet stringent ... CE marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE marking indicates that an IVD device complies with the European In-Vitro ... Sep 17, 2022 ... A CE marking cannot legally exist on its own, it has to be backed by a declaration of conformity which in turn has to be backed by appropriate ... The CE marking shall be affixed before the product with digital elements is placed on the market. It may be followed by a pictogram or any other mark indicating ...