on New MDR
ECM notified body 1282
Great certification processes are simple ones. The most powerful live at the intersection of clarity, competences
ECM has applied for the transition to MDR and extended the certification scope to 80% of the NBOG Codes including many Class III
EU MDR (Medical Devices Regulation)
For decades, regulation of the medical device industry in Europe has been rather unchanged. However, recent events have now prompted for vital regulatory & compliance reforms to the medical devices industry. The new Medical Devices Regulation adopted by
To meet the new EU MDR objective, organizations will need to take a structured and well-managed approach over the next 3 years depending on the product portfolio.
MDR: What is new?
The MDR introduces numerous new requirements and concretizes requirements of the MDD.
The essential requirements – now renamed as “essential safety and performance requirements” – are much more specific.
UDI & Labeling
Like the FDA, manufacturers now must assign a unique device identification (UDI).
New roles inside manufacturing companies
Manufacturers must employ (exception for small companies) a “person responsible for regulatory compliance”.
Creation of the EU database (EUDAMED).
Clinical Evaluation and PMCF (post-market clinical follow-up)
The MDR increases the requirements for Clinical Evaluation and PMCF.
The post-market surveillance is regulated in detail.
Classification and conformity assessment procedures
Changes in conformity assessment procedures and device classification rules.
Possible introduction of “common specifications” (CS) if harmonized standards are lacking or insufficient.
MDR Critical Update:
ECM is proud to announce that has submitted designation applications for the Medical Devices Regulation (Regulation (EU) 2017/745 link to Europe website) to both the Italian Competent Authorities.
The next step is for the Designating Authority, Italian Ministry of
ECM is committed to