As part of the overall ‘Concept to Completion’ service, Europlaz can provide support and assistance with the Regulatory / CE Marking processes ranging from individual Technical File elements to managing the complete CE Marking process including the generation and maintenance of the Technical File and supporting documentation.
In order to apply a CE Mark to a medical device it is necessary to demonstrate that the device meets the requirements in the appropriate Medical Device Directive / Medical Device Regulation by carrying out a comprehensive conformity assessment.
Determine the intended use of the product
Clearly and concisely define the intended use of the product.
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: Class I is the lowest risk category; Class IIa is considered low to medium risk; Class IIb is medium to high risk and 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.
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.
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. This is why an accurate classification of the device is a critical upfront step in the assessment process.
A Technical File must be compiled that describes the design and manufacture of the product, and the objective evidence to demonstrate how conformity with each of the applicable requirements has been achieved.
In order to ensure that incidents are assessed and where applicable reported to the national competent authority and to review information gained in the post market phase, a Post Market surveillance system must be implemented.
Once all other steps 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.
Read more about our news on medical device manufacturing and development in the UK