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on New MDR

ECM notified body 1282

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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 EU, is replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive.

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.

Essential requirements

The essential requirements – now renamed as “essential safety and performance requirements” – are much more specific. Consequently the technical documentation is more closely regulated.

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”.

EUDAMED
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.

Post-Market Surveillance

The post-market surveillance is regulated in detail.

Classification and conformity assessment procedures

Changes in conformity assessment procedures and device classification rules.

Common specifications

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 Health , to review our application and to prepare the report to be forwarded to the European Commission so to have Joint Assessment audits of ECM scheduled.

ECM is committed to work toward the designation of MDR and will continue to endeavor for distinction in our Notified Body activities over the transition period. We will ensure that you are kept up to date with the progression going forward.