Entering the European market presents hurdles that may cause delays in the introduction of your product. Delays like these can be expensive for both the company and the individuals who need care. However, there are strict criteria to assure the safety of patients and users and the device’s functionality.
In the United Kingdom, there are numerous Notified Bodies that examine medical devices to determine whether it satisfies the specified standards of European Regulatory frameworks.
Under the current UKCA program, these Authorized Bodies are eligible to undertake conformity assessments.
What is CE marking, and why is it important?
CE marking is a regulatory requirement for placing a product in the marketplace in the EU. It certifies that an item meets the GSPR (General Safety and Performance Requirements) of the applicable European Medical Device Guidelines.
You must categorize the device and determine the suitable conformity assessment method for your device to understand which standards you must meet. This establishes the activities that must be completed in order to demonstrate conformance.
The notified bodies will examine the route you selected to ensure its suitability and will also collaborate with you to carry out the most expedient review process possible. Their tried-and-true review processes let you plan CE marking projects with confidence and reliability.
How can you get a CE mark?
To get a CE mark medical device must meet the criteria of a medical device and be suitably categorised according to Annex VIII of the European Union medical devices legislation in order to receive CE mark medical device. There are four risk categories for medical devices: There are four risk categories:
• I (Im
• IIb and III
Class I carries the lowest risk, while class III carries the most. The CE mark medical device process is done by the producer in the class I devices. A notified entity conducting the certification should complete CE mark medical device process for high-risk classes.