LONDON--(BUSINESS WIRE)--The new European Medical Devices Regulation (MDR) will penetrate the European market by replacing the existing Active Implantable Medical Device Directive (AIMDD) and the Medical Device Directive (MDD). Market Intelligence firm, Infiniti Research, recently shared their thoughts on these new regulations and how manufacturers can deal with it.
Infiniti Research notes that, “The new MDR will be acting as a major game changer in the industry. The addition of new elements like transparency and product traceability, in the new regulation will ease up the complex medical device environment in the European market.”
Since 2010, Europe has been witnessing a huge number of hip replacement recalls and a breast implant crisis. The high incidence of such unsuccessful attempts highlights the loopholes in the existing regulations and underlines the need for a new set of guidelines which can address the present-day medical complexities. This has given birth to the new idea of MDR.
The adoption of the new MDR will help in impartial assessment of the safety and performance of the medical devices before being sold in the EU market, standardizing rules for unproblematic trading between the members of the Union, meeting specific needs of medium and small-sized manufacturers to be considered, providing transparency of information and patient-oriented innovation, along with comprehensive assessment of the risk-benefit aspect of the devices.
In its recent assessment of the effects of MDR on the European market, Infiniti Research found that early preparation and adoption is the key to make a mark in the European market and leverage the regulations to one’s advantage. In the upcoming three years, manufacturers of medical devices must cohere to a well-structured approach, depending on their product portfolio. Manufacturers can start by understanding the compliance data at the micro level for at least two to three of their products.
In order to get a clear picture of the areas which need focused attention, the technical documentation of these devices needs to be submitted to the Notified Bodies. Gap analysis can help manufacturers in figuring out areas which need to be fixed to comply with the new regulations. After evaluation of the products, changes can be easily made to the wide range of medical device portfolio – much earlier before MRD comes into force.
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About Infiniti Research
Established in 2003, Infiniti Research is a leading market intelligence company providing smart solutions to address your business challenges. Infiniti Research studies markets in more than 100 countries to help analyze competitive activity, see beyond market disruptions, and develop intelligent business strategies.
With 13 years of experience and offices across three continents, Infiniti Research has been instrumental in providing a complete range of competitive intelligence, strategy, and research services for over 550 companies across the globe.