CE Marking Medical Devices
CE Marking Medical Devices
Europlaz can assist medical device and IVD manufacturers in obtaining a CE mark for both UK and EU markets.
Class I or IIa Medical Device CE Mark Applications on Your Behalf
As part of the overall ‘concept to completion’ service, Europlaz can support the Regulatory CE Marking processes for medical devices. Services range from individual Technical File elements such as testing and production documentation to managing the complete CE Marking process, including the generation and ongoing maintenance of the Technical File.
In order to apply a CE Mark to a medical device, it is necessary to demonstrate the device meets the requirements in the appropriate Medical Device Directive / Medical Device Regulation by following the relevant, comprehensive conformity assessment procedures.
Click here to see all the medical device regulations you need to know about in 2022 in addition to CE Marking.
How to get a CE Certification for your Medical Devices
To qualify your medical device or product for CE marking certification, you need to determine the intended use of the product.
Clearly and concisely define the intended use of the product.
- What medical condition is the product intended to diagnose or treat?
- What is the mode of action of the product?
- Who is the intended user (layperson / professional)
- What patient population will the product treat?
These questions will help determine if your product falls under the CE medical device mark requirements. If you need a hand determining whether you need CE certification for a medical device, please feel free to contact us and we can help with a wide range of medical device manufacturing services.
Determine the Risk Classification the Product falls into
The Medical Device Directive / Medical Device Regulations detail the rules for determining the classification of the product. These classification rules are based on risk and include examples of factors that influence the associated risk.
There are four classification categories to certify medical devices for CE marking:
- Class I is the lowest risk category
- Class IIa is considered low to medium risk
- Class IIb is medium to high risk
- Class III is the highest risk category
In addition, there are 2 sub-classes for Class I: Class I devices that are sterile and Class I devices that have a measuring function.
Find out more about the changes to risk classifications in the UK following Brexit and in the EU following the introduction of the EU MDR here.
Determine Compliance with the Essential / Safety & Performance Requirements
The Medical Device Directive / Medical Device Regulations detail the Essential / Safety and performance requirements for all classes of medical devices, and includes requirements for safety, performance, design and construction, as well as labelling and instructions for use. If the Requirement is applicable to the Device in question it must be complied with.
Determine the appropriate Conformity Assessment Procedure
The Annexes of the MDD / MDR details the various procedures for demonstrating conformity and it is the responsibility of the manufacturer to choose the appropriate procedure based on the classification of the product. The choice of assessment route dramatically affects the complexity and scope of the assessment. Therefore an accurate classification of the device is a critical upfront step in the assessment process.
Compile the Technical Documentation
A Technical File must be compiled describing the design and manufacture of the product, and the objective evidence to demonstrate how conformity with each of the applicable requirements has been achieved.
Read more about the technical files required for CE medical device certification here.
Implement Post-Market Surveillance
In order to ensure incidents in the market are assessed and, where applicable, reported to the national competent authority a Post Market surveillance system must be implemented. This process reviews all information gained once the device is being used in the market and ensures key information is fed back into the ongoing risk analysis in the technical file.
Issue the Declaration of Conformity and Affix the CE Mark
Once all other steps to qualify your medical device for CE marking have been satisfactorily completed and approved, a declaration of conformity to the Medical Device Directive / Regulation is made. This affirms that the device meets all of the applicable essential / safety and performance requirements, has undergone the appropriate conformity assessment procedure and is designed, manufactured and tested in accordance with the Technical documentation. A ‘Declaration of Conformity’ to the MDD / MDR can be generated and signed, and the CE Mark applied to the device so that it can be sold throughout the EU.
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