Market
surveillance activities are performed by competent authority to ensure that
device meets the MDR.
CA
shall perform appropriate checks on the conformity characteristics and
performance of devices.it will review the documentation and physical or
laboratory checks based on adequate samples.
Every
CA shall allocate an enough
material and competent human resources in order to carry out those activities
and prepare annual summary activity plans.
CA shall prepare an annual summary of the results
of their surveillance activities and make it accessible to other competent
authorities through Electronic system on market surveillance.
Flow :
CA Prepare annual summary activity plans—Medical
device inspection to verify MDR compliance –Inform economic operator & get
comments from them –CA will upload the report in electronic system.
Member states will check the CA market surveillance
activities at least every four years and the results shall be
communicated to the other Member States and the Commission.
Article 94 discuss that CA shall evaluate the devices
that may present an unacceptable risk to the health or safety of patients,
users or other persons, or to other aspects of the protection of public health;
or otherwise does not comply with MDR.
Economic operators need to take appropriate and duly
justified corrective action to bring the device to compliance with MDR.if not,
CA will perform below actions (MDR Article 95 & 97/IVDR Article 91 &
92))
·
Restrict
the making available of the device on the market
·
Making
available of the device to specific requirements
·
Device
withdrawal
·
Device
recall
References
REGULATION (EU) 2017/745 OF
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices,
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC)
No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
REGULATION (EU) 2017/746 OF
THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive 98/79/EC and Commission
Decision 2010/227/EU
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