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Understanding Europe's New
Medical Device Regulation - MDR 2017/745
Mr. Sanjay Shah
Managing Director
Unikal Consultants, Ahmedabad
• Why MDR replaces MDD/93/42
• What are the key changes of the regulation?
• What is the scope of the regulation?
• How will EUDAMED and other databases change?
• Factors to consider when timing your transition to the MDR, and...
You've probably heard that Europe's well-established
medical device regulations are about to change. And you probably have a lot of
questions. What do these changes mean and how will they affect your company?
Europe's new Medical Device Regulation (MDR) will
bring substantial changes to the way medical device manufacturers bring their
devices to the European market, and how they maintain compliance throughout the
product's life cycle. Why MDR?
The European Medical Device Regulation (EU MDR)
ensures high standards of quality and safety for medical devices being produced
in or supplied into Europe. It has brought in a fundamental revision in 2017 to
better identify medical devices products and improve transparency through
standard data, technological advances and the establishment of an EU database (Eudamed).
Similar to the FDA’s UDI, EU MDR will establish a robust, transparent,
predictable and sustainable regulatory framework for medical devices to ensure a
high level of health and safety whilst supporting innovation.
The new regulations seek to increase medical device
safety and effectiveness in the EU Market while addressing weaknesses revealed
in the implementation of Medical Device Directives by several medical device
manufacturers. The MDR and IVDR also are a response to technical and scientific
developments that are quickly shaping the medical device industry.
What will new MDR intend to achieve?
Until now, different European countries have
interpreted and implemented the directive in different ways. By revising the
directive EU MDR will enforce:
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Stricter pre-market control of high-risk devices at
an EU level
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The inclusion of certain aesthetic products which
present the same characteristics and risk profile as equivalent medical devices
e.g. contact lenses
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A new risk classification system for diagnostic
medical devices based on international guidance
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Improved transparency through the establishment of a
comprehensive EU database of medical devices (Eudamed)
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Device traceability through the supply chain from
its manufacturer through to the final user including importer, distributor
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An EU-wide requirement for an 'implant card' to be
provided to patients containing information about implanted medical devices
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the reinforcement of the rules on clinical data and
clinical studies on devices
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Manufacturers to collect data about the real-life
use of their devices
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Improved coordination between EU Member States
The main reasons behind this change**
Problems with diverging interpretation of the
current Directives as well as the incident concerning fraudulent production of
the PIP silicone breast implants highlighted weaknesses in the legal system in
place at the time and damaged the confidence of patients, consumers and
healthcare professionals in the safety of medical devices. Such problems should
not occur again and the safety of all medical devices available in the EU has to
be strengthened. Moreover, revision of the legislation was necessary to
consolidate the role of the EU as a global leader in the sector over the
long-term and to take into account all technological and scientific developments
in the sector.
The new regulations will ensure:
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a consistently high level of health and safety
protection for EU citizens using these products
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the free and fair trade of the products throughout
the EU
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that EU legislation is adapted to the significant
technological and scientific progress occurring in this sector over the last 20
years
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Also refer to Factsheet for Manufacturers of Medical
Devices in EU guidance document
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