A CE Marking is a much sought-after symbol, as it allows companies to gain access to the large European market. CE Marking indicates the conformity of products to the applicable regulatory requirements, and the performance and safety standards. It signifies that the product is suited for its intended use and won’t put people or property in danger. Whether it is after self-declaration or after a notified body’s approval, placing a CE Mark, unless exempt, is a must for any company that is looking to sell its products in the EU market.
Which products need a CE Mark?
CE marking is required for products that fall under the scope of the following Directives and Regulations:
- Regulation (EU) 2017/745 on Medical Devices
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- Directive 2014/30/EU relating to Electromagnetic Compatibility
- Directive 2014/53/EU relating to Radio Equipment
- Directive 2014/68/EU on Pressure Equipment
To whom is the CE Marking applicable?
CE Marking is applicable not only to products to be marketed but also to products that are manufactured and are to be sold in the EU Region. A producer, importer, or person in charge of putting the product on the EU market should be able to provide, upon request, the necessary technical documentation to support the use of the CE mark.
How can one get a CE Mark?
In order to get a CE Marking the very first step is to identify the classification of the product, and whether or not it would be eligible for a self-declaration and exempt from a Notified Body (NB) review. If the self-declaration claim is contested, relevant evidence must be provided to support the assertion. Both compliance with Quality Management Systems (QMS) and the regulatory requirements are needed for a successful CE Marking based on the device’s classification.
There are a number of directives and regulations, related to each type of product, that manufacturers must comply with in order to attain the CE Mark. A medical device company must choose the applicable conformity assessment path for their product in order to know which standards one needs to comply with. This establishes the necessary flow of actions to show conformance. The importer and/or producer must take steps to comply with safety rules, create the necessary documents, and decide on the necessary procedures to keep production in accordance with the directives.
How can compliance with CE Mark be known?
Compliance with CE Marking can be known by affixing a CE Mark. For this, the manufacturer must comply with the requirements provided in the Regulation, EU MDR 2017/745, for the product, and the quality management system of the company. Manufacturers also need to complete the applicable conformity assessment route with the help of the Notified Bodies for obtaining the CE Marking for their products. The CE Mark must be displayed on the labeling to demonstrate compliance with the directives’ provisions.
What is the benefit of a CE Mark?
Apart from legal compliance and the manufacturer’s declaration that the product satisfies the General Safety and Performance Requirements (GSPR) of all applicable European Medical Device Regulations, it is well known that the products with a CE Mark have a high degree of inbuilt safety for human health, public, and the environment. Since CE Mark, the manufacturer considers the most recent state-of-the-art practices with regard to health, safety, and environmental protection, consumers and users using CE-marked products are well protected.
Who bears the responsibility associated with a CE Mark?
While there can be several parties involved in sharing responsibility or tasks related to the process of CE Marking, from a legal perspective a Legal Manufacturer bears the sole responsibility for the safety of the device placed in the market under a CE Mark. The Legal Manufacturer must ensure continued compliance with all the appropriate requirements associated with the CE Mark.
What’s the challenge?
Getting a CE Mark can be a big challenge and an arduous task. Figuring out the different regulations and guidelines that are applicable to your device is surely cumbersome, and incorrect identification of the applicable directives, classification, and requirements can result in lost time and resources. We, here at Elexes, can help you navigate through these directives and regulations and put technical documentation and other relevant information in place very efficiently. Elexes has a team of regulatory and quality professionals who have helped numerous medical device companies enter the EU Market to sell their products. Please feel free to write to us at firstname.lastname@example.org or dial +1 650-503-6615 for further questions.
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.