CE marking for Annex-XVI products

1. CE Marking for Annex-XVI Products www.mavenprofserv.us

2. Overview Importance of CE Marking for Annex-XVI Products How are “Annex XVI products” classified? Compliance requirements for Annex-XVI products Transitional timelines for CE marking of AnnexXVI products

3. Importance of CE Marking forAnnex-XVI Products In the world of product manufacturing and distribution, compliance with safety standards is of utmost importance. In particular, Annex-XVI products require special attention when it comes to meeting regulatory requirements. This is where CE marking comes into play.

4. In this comprehensive overview, we delve into the significance of CE marking for Annex-XVI products, uncovering its importance and the impact it has on manufacturers, distributors, and end-users. From medical devices to construction products, CE marking ensures that these products adhere to essential health, safety, and environmental protection standards. Join us as we unravel the importance of CE marking for Annex-XVI products and unlock the key to regulatory compliance and market success.

5. How are “Annex XVI products” classified? Annex XVI of Regulation (EU) No. 2017/745 on medical devices (EU MDR) outlines criteria for determining whether certain products should be classified as medical devices. These products are referred to as “Annex XVI products.” Annex XVI lists products that are excluded from the definition of medical devices under the EU MDR.

6. CE marking is a mandatory requirement for Annex-XVI products sold within the European Economic Area (EEA). It indicates that a product has undergone the necessary conformity assessment procedures and meets the essential health, safety, and environmental protection requirements set out by the European Union (EU). CE marking provides assurance to manufacturers, distributors, and end-users that the product is safe and compliant with applicable regulations.

7. ComplianceRequirements for Annex-XVI Products The compliance requirements for Annex XVI products, also known as devices without an intended medical purpose, are outlined in the European Union’s Medical Device Regulation (EU MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). These requirements include the following:

8. Classification Conformity Assessment Procedure Technical Documentation Common specifications Declaration of conformity Post-market surveillance Unique Device Identifier (UDI)

9. Person responsible for regulatory compliance Registration in EUDAMED Labeling and instructions for use Vigilance reporting

10. Transitional timelines for CE marking of Annex XVI products Annex XVI devices that do not require notified body conformity assessment dont have the benefit of transitional provisions and must comply with the EU MDR from the date of application of Regulation (EU) No. 2022/2346, i.e. 22 June 2023.

11. In the context of Annex XVI products subject to the EU Medical Device Regulation (MDR), Regulation (EU) No. 2022/2346 has introduced revised deadlines aligned with the transitional periods specified in Regulation (EU) 2023/607. The deadlines for application under the EU MDR depend on whether the manufacturer plans to conduct a clinical trial.

12. These adjustments in timelines aim to accommodate the transitional provisions introduced by Regulation (EU) 2023/607. Manufacturers are required to adhere to the specified deadlines and conditions to ensure compliance with the EU MDR. It is advisable for manufacturers to stay informed about any updates, amendments, or additional guidance provided by regulatory authorities to ensure accurate and timely compliance.

13. Contact Us https://mavenprofserv.us/ce-marking-for-annex- xvi-products/ md@mavenprofserv.us