Unveiling the Importance of CE Marking for Annex-XVI Products: A Comprehensive Overview
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.
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.
We explore the process of obtaining CE marking, the various directives and regulations that apply, and the consequences of non-compliance. By understanding the intricacies of CE marking, manufacturers can navigate the complexities of the market and ensure their products meet the necessary standards, boosting trust among customers and driving growth.
Join us as we unravel the importance of CE marking for Annex-XVI products and unlock the key to regulatory compliance and market success.
What are devices without an intended medical purpose?
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. These devices without an intended medical purpose or used for aesthetic purposes but are similar to medical devices in terms of functionality and risk profile and hence classified as “devices” under the EU MDR.
Annex-XVI refers to a category of products that are subject to specific regulations and directives to ensure their safety, quality, and environmental impact. These products cover a wide range of industries, including medical devices, construction products, machinery, electrical equipment, and more. The purpose of Annex-XVI is to safeguard the health and safety of consumers, as well as the environment.
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.
How are “Annex XVI products” classified?
Even though devices without an intended medical purpose are classified like every other medical devices using the classification rules set out in Annex VIII of the EU MDR, devices without an intended medical purpose that are active in nature can not be classified based on these classification rules as Rule 9 and Rule 10 are exclusively applicable to devices with a medical intended purpose. However, Commission Implementing Regulation (EU) 2022/2347, lays down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose.
Compliance requirements for Annex-XVI products (devices without an intended medical purpose)
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:
- Classification:
Annex XVI products are classified as stated above using the same classification rules as medical devices. Most of the Annex XVI product are either Class I or Class IIa, depending on their level of risk to patients and users. Class I products have lower risk, while Class IIa products have moderate risk. - Conformity assessment procedure:
Manufacturers of Annex XVI products must undergo a conformity assessment procedure to demonstrate that their products meet the applicable requirements. The procedure depends on the classification of the product and may involve self-certification or involve a Notified Body. - Technical documentation:
Manufacturers must prepare technical documentation that includes information on the design, construction, and performance of the product. This documentation must be kept up to date and made available to relevant authorities upon request. - Common specifications:
Common specifications for the groups of products without an intended medical purpose listed in Annex XVI have been published in Regulation (EU) No. 2022/2346.These include product specific requirements related to risk management, safety requirements and information for safety - Declaration of conformity:
Manufacturers must issue a declaration of conformity stating that their product complies with the applicable requirements of the EU MDR or IVDR. - Post-market surveillance:
Manufacturers have an obligation to monitor the safety and performance of their products once they are on the market. This includes establishing a post-market surveillance system, investigating incidents and complaints, and reporting serious incidents to the competent authorities. - Unique Device Identifier (UDI):
Annex XVI products must be labeled with a Unique Device Identifier, which is a series of numeric or alphanumeric codes that allow for the identification and traceability of the product. - Person responsible for regulatory compliance:
Manufacturers must designate a person responsible for regulatory compliance (PRRC) who has the necessary qualifications and responsibilities to ensure compliance with the regulations. - Registration in EUDAMED:
EUDAMED is the European database on medical devices, and manufacturers must register their Annex XVI products in this database before placing them on the market. - Labeling and instructions for use:
Annex XVI products must be labeled and accompanied by instructions for use that provide clear and accurate information to users, including proper handling, storage, and disposal instructions. - Vigilance reporting:
Manufacturers have an obligation to report any incidents or field safety corrective actions related to their Annex XVI products to the competent authorities within specific timeframes.
It is important for manufacturers of Annex XVI products to thoroughly understand and comply with these requirements to ensure the safety and efficacy of their products and to meet regulatory obligations.
In instances involving products without an intended medical purpose as outlined in Annex XVI, the obligation to establish a clinical benefit, as stipulated in this Chapter and Annexes XIV and XV, should be interpreted as the necessity to validate the device’s performance. Evaluations of the clinical aspects of these products must be grounded in pertinent safety data, incorporating information from post-market surveillance, PMCF (Post-Market Clinical Follow-up), and, when relevant, specific clinical investigations. Clinical investigations are required for such products unless a well-justified reliance on existing clinical data from a comparable medical device is demonstrated.
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.
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.
For Manufacturers Intending to Perform or Performing a Clinical Trial:
- Original Deadline: 22 June 2028.
- Revised Deadline: Extended to 31 December 2029.
- To qualify for this extended deadline, manufacturers must have signed a written agreement with a Notified Body for conformity assessment under the EU MDR starting from 01 January 2028.
For Manufacturers Not Planning a Clinical Trial:
- Original Deadline: 22 June 2025.
- Revised Deadline: Extended to 31 December 2028.
- To benefit from this extended deadline, manufacturers must have signed a written agreement with a Notified Body for conformity assessment under the EU MDR starting from 01 January 2027.
It is essential to note that these transitional timelines come with certain conditions. Specifically, the Annex XVI product must have been lawfully marketed before 22 June 2023, and no significant changes should be made to its design and intended purpose.
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.