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EU Medical Device Regulation (MDR) - Coggle Diagram
EU Medical Device Regulation (MDR)
came into force1 on 25 May 2017
but due to the COVID-19 emergency,the new MDR became effective on 27 May 2024.
From that date, only medical devices, with a valid EU certificate of conformity may be placed on the market.
aims to improve patient protection2 avoiding health risks and ensuring traceability of products.
REGULATIONS and DIRECTIVES
A directive
is a European act that sets out a goal that the Member States must achieve,but leaving them free to choose the rules for achieving this target, by means of national laws.
A
regulation
, on the other hand, is a binding legislative act. It must be applied by all member State
What is a custom-made device (CMD)?
made in accordance with a written prescription of any person authorized by national law for his professional qualifications;
the prescription gives specific design characteristics under that person's responsibility;
must include the following information:
the patient’s clear identification
the complete and detailed design of the medical device
the recipient manufacturer
the device is intended for the use of a particular patient to meet his individual conditions and needs.
Manufacturers of custom-made devices they must draw up a statement, that is a Declaration of Conformity for each device.
The Dental Lab Assessment
reviews the prescription and may highlight, in a written statement, the potential risks connected to the processing of the received prescription.
The Finished Device
documentation as to his work procedure
a label and a package leaflet, including instructions on how to maintain the device properly
a declaration of conformity to the EEC 93/42
a technical folder17 with exhaustive information on the device
The manufacturer has also the duty to store in an archive, for at least 10 YEARS
the prescription
the declaration of conformity
the leaflet for instructions