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.

Until now, different European countries have interpreted and implemented the directive in different ways. By revising the directive EU MDR will enforce:

Stricter pre-market control of high-risk devices at an EU level

The inclusion of certain aesthetic products which present the same characteristics and risk profile as equivalent medical devices e.g. contact lenses

A new risk classification system for diagnostic medical devices based on international guidance

Improved transparency through the establishment of a comprehensive EU database of medical devices (Eudamed)

Device traceability through the supply chain from its manufacturer through to the final user including importer, distributor

An EU-wide requirement for an 'implant card' to be provided to patients containing information about implanted medical devices

the reinforcement of the rules on clinical data and clinical studies on devices

Manufacturers to collect data about the real-life use of their devices

Improved coordination between EU Member States

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.

a consistently high level of health and safety protection for EU citizens using these products

the free and fair trade of the products throughout the EU

that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years

Also refer to Factsheet for Manufacturers of Medical Devices in EU guidance document