All medical device manufacturers should be aware that the last CE certificate renewal deadline expires later this month. Those who miss it could face regulatory issues, delays, and additional expenses.

CE Certificate Renewal Requirements

According to the Medical Device Regulation (MDR 2017/745 EU), all medical device manufacturers should renew the CE safety conformity certificate for their products obtained under the Medical Device Directive (93/42/EC) that had been replaced by the MDR. The Regulation enters into effect in May 2020, so manufacturers have to renew certificates for existing products prior to that date. In accordance with the new rules set forth by the MDR, appropriate submissions should be filed to Notified Bodies – special entities designated by national regulating authorities to perform functions in the sphere of medical device circulation. Notified Bodies are responsible for reviewing new medical device applications. The issue is that there are only a few entities designated at the moment which creates grounds for reasonable concerns that they will not be able to handle the substantial number of submissions filed by medical device manufacturers within a short period of time. This situation could probably lead to delays in medical device supply that could be harmful for healthcare institutions and patients using such devices. This is the primary reason as to why medical device manufacturers strongly recommend to accelerate the renewal process to be able to market their products within the European Union. 

 

 

Terms and Timelines

As for now, medical device manufacturers have two options, depending on the expiration date of the certificates. They are:

  • To renew the existing certificate in accordance with the MDD
  • To file for the certificate issued under the MDR.

The second approach is preferable since it simplifies further procedures. Notified Bodies already have the responsibility of reviewing submissions under the MDR. The reclassification process required under the new regulations should be completed as soon as possible. After this, medical device manufacturers would have to notify authorized bodies on any important changes to the medical device, its functions, and purpose. The whole renewal process could take four months or even more since Notified Bodies are likely to be overloaded with submissions. Some of these Notified Bodies already ceased to accept submissions for Class IIa, Class IIb and Class III medical devices while the acceptance of submissions for Class I (Sterile or Measuring devices) would be suspended at the end of August, so medical device manufacturers have very limited time to file an application for the CE certificate renewal. The acceptance suspension dates set by different Notified Bodies may vary, but in general they are almost the same. 

 

 

About RegDesk™

RegDesk’s platform provides medical device manufacturers with important updates and changes to regulations in a reliable and timely manner. Compliance with Medical Device Regulations is important for any manufacturer that plans to distribute its products in the EU market. Regulatory requirements incur substantial changes in the market, and to be aware of new amendments and improvements while maintaining compliance with all applicable regulations is extremely pertinent.

0 Comments

Submit a Comment

Your email address will not be published. Required fields are marked *