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? Complianc
e requirements for Annex-XVI products
Transitional timelines for CE marking of Annex
XVI products
3
Importance of CE Marking for Annex-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
Compliance Requirements 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 Unions Medical Device Regulation (EU
  MDR) and In Vitro Diagnostic Medical Device
  Regulation (IVDR). These requirements include
  the following

8

1. Classification
2. Conformity Assessment Procedure
3. Technical Documentation
4. Common specifications
5. Declaration of conformity
6. Post-market surveillance
7. Unique Device Identifier (UDI)

9

1. Person responsible for regulatory compliance
2. Registration in EUDAMED
3. Labeling and instructions for use
4. 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_at_mavenprofserv.us