EXTENSION OF THE PERIODS OF ADAPTATION OF MEDICAL DEVICES TO MDR 2017/745 and IVDR 2017/746

Due to the high volume of medical devices in the process of certification, the European Commission has decided to extend the adaptation periods to these regulations, extending until 2027 o 2028, depending on the product concerned.

You can find more information about it in the statement issued by the European Commission: https://health.ec.europa.eu/system/files/2023-01/mdr_proposal.pdf

Or if they want, You can consult us and we will be happy to answer your questions.

ADAPTATION OF TECHNICAL FILES TO NEW REGULATIONS:
MEDICAL DEVICES ACCORDING TO REG (EU) 2017/745 AND PRODUCTS
IN VITRO DIAGNOSTIC SANTARIOS ACCORDING TO REG (EU) 2017/746.

Preparation of new sections to be included and/or reviewed in the files:

  • Summary on safety and postclinical functioning (PMCF)
  • Clinical evaluation
  • Post-marketing follow-up
  • Product Safety Tracking Summary (PSUR)

According to European Regulations 2017/745 for medical devices and 2017/746 for in vitro diagnostic medical devices, it is necessary that this class of products have CE Marking, demonstrating that they comply, Therefore, with all the requirements defined by regulations.

In this way, in order to obtain the CE marking, a series of elements will be necessary, Where can we find

 

  • Product Classification:
    • Medical devices: From lowest to highest risk, Class I products are available, Sterile Class I and Class I with measuring function, Class IIa, Class IIb and Class III.
    • In vitro diagnostic medical devices: also depending on the risk there are classes A, B, C & D.
  • Preparation of technical file, in which sections such as:
    • Product Description and Specifications
    • Labelling
    • Design and Manufacturing Information
    • General safety and performance requirements
    • Benefit-risk analysis and risk management
    • Product validation

 

  • Company registration on platform EUDAMED (European Medical Device Database), from where the Unique Registration Number will be assigned (SNA), that allows the identification of the requesting entity in the database.
  • Obtaining UDI code: Unique Identification Code that allows identification and facilitates the traceability of products.
  • Processing with Notified Body.

 

At Burotec we can advise you all the way to obtain the CE marking of your products, accompanying you in all phases of the project and guiding you through all the necessary procedures.

To learn more about our services and how we can help, You can send your inquiry to inFo@burotec.es or call to the +34 913768950 and request information without commitment, We are at your disposal.

CE MARKING: HEALTH PRODUCT

 

CE MARKING: HEALTH PRODUCT

 

 

Sanitary productMark CE: health care product