How has EU-MDR affected CE Marking for Medical Device Manufacturers?

Effect of EU-MDR on CE Marking- 

There are many differences between MDD and MDR, as MDR is more detailed and comprehensive. MDR ensures that all medical device manufacturers have fair access to all the markets of the EU and that medical devices are safe, have high quality, transparent for customers, and have increased market surveillance. The changes in MDR have many aspects which will affect the CE marking process, which are given below:

Reclassification 

• In EU-MDR, medical devices are classified as per the risk they possess. Thus, it helps to determine the route for CE marking. While the overall classification of medical devices remains the same in MDR from class I to class III, EU-MDR reclassified some devices. So, from now, the manufacturers need to accurately classify their devices and determine which conformity route they need to follow. Thus, reclassified devices that were placed in the higher group due to their risk needed technical and clinical data as they may not be already available. 

• For the manufacturers of high-risk class devices such as class IIa, class IIb and class III, it is mandatory to involve a notified body to obtain the conformity assessment. 
• The class I device manufacturer can use the self-certify route to get the CE marking. 

Clinical Evaluation Reports (CERs) 

• CERs are the documents that contain clinical data related to the medical. The MDR has clearer information regarding the clinical evidence and evaluation (MDR Annex XIV, Part A). The use of scientific literature to establish equivalence has become stricter after this regulation, along with increased scrutiny of CER by notified bodies. It is important for manufacturers, especially class I medical devices, to ensure that CERs conform to new specifications. In class, I have less additional clinical data to support.  

Does My Device Fall Under Self-Certification? 

The first and main step in determining the route for CE marking is classification, which depends on the intended use and risk involved. The class I medical devices are mostly nonsterile and do not have any measuring function; thus, do not require a notified body for conformity assessment. 

Validity of CE Marking

The MDR came into full effect in May 2021, and the CE certificates issued before MDR have validity for four years. The certificates issued after MDR implementation have validity for three years. For some high risks devices, it is up to one year. 

Things to Keep in Mind While Affixing the CE Mark: 

• It must be visible, legible, and permanent. 
• Must have the initials “CE” with the same vertical dimension and should not be less than 5mm (unless specified). 
• The manufacturer can use it in different forms if CE marking is visible. 
• Suppose the manufacturer cannot affix the CE marking on the medical device itself. In that case, it can be affixed to the packaging if there is any or can accompany the documents. Suppose the device is subjected to several EU directives. In that case, documents must indicate that the device conforms to all the applicable directives. 

• Our technical experts can assist you in getting your medical devices CE-approved.

Conclusion

The MDR has significantly changed how a CE mark certificate gets approved in Europe. The changes were extensive, and it took the organization time to implement the MDR fully. These changes have affected the manufacturer, their organization, and notified bodies. The CE marking is proof from the manufacturer that the medical device adheres to the EU-MDR. Thus, the manufacturer now needs to be more careful with it if they want to continue the business all over the European market. As medical device regulatory consultants we guide manufacturers and help them to obtain CE marking medical devices.