MDR

Medical Device Regulation Adopted

COCIR welcomes the adoption of the Medical Device Regulation (MDR) after successful vote during the European Parliament Plenary Session today. These new rules should allow for continuing improvement to the safety of medical devices, benefitting patients and ensure timely access to innovative healthcare technology.

Photo: Medical Device Regulation Adopted

In 2012, the European Commission set out to revise the legislative framework for medical devices to keep  pace  with both the rapidly-changing  technological  environment  and  specific  challenges. Following four  years  of  debate and  discussion, we  believe  that the  MDR  will increase consistent interpretation across Member States, supporting a transparent regulatory framework. It will enhance traceability through a unique identification number and a central database, which will be accessible to all stakeholders. It also provides a stronger mandate for notified bodies and oversight for national authorities and enhanced responsibilities for manufacturers and other economic operators.

However, the  most critical aspect  for ensuring the  timely access  of  patients to  innovative medical devices is the successful  implementation of  the  Regulation. Therefore, COCIR looks forward  to continuing to support the European Commission and Member States during this critical phase. COCIR 
is ready to provide support during development of the corresponding delegated and implementing acts.

Nicole Denjoy, COCIR Secretary General, says “COCIR members that provide innovative technologies and  services believe that  the ongoing innovation  in medical  devices will  continue  to contribute significantly  to  the  health  and  well-being  of EU citizens. Medical  technologies  sectors covered  by 
COCIR provide solutions covering the entire continuum of care, from diagnosis, through prevention, monitoring,  treatment, alleviation to aftercare.” She adds, “This  is  why  the  European  regulatory framework  should  continue  its  evolution, providing the foundation  for  safe  and  effective  medical technologies  to  come to market  in  synchronisation  towards  global  regulatory  convergence. Good regulations  should  work  to  both  enhance  patient  safety  and help innovative  solutions reach  the market in a timely manner, helping avoid unnecessary administrative burdens that could potentially increase overall costs and prevent citizens and patients from realising the full benefits”.

COCIR is committed  to  working with regulators  and all  stakeholders in supporting a  seamless transition from the Medical Device Directive to the Medical Device Regulation. This will ensure that patients across the EU continue to benefit from timely diagnoses and access to the latest advances in medical technology.

Source: press release COCIR

 

06.04.2017

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