The European Parliament Representatives (EP) and the European Parliament’s Environment and Health Committee reached a agreement politically on the new Medical Devices Regulations and In-Vitro Diagnostic Devices (IVD) Regulations.
Following a legal linguistic review of the 2 documents planned for September, according to the EU Council and Parliament could adopt the two draft regulations by the end of 2016. These new rules will apply 5 years after publication for In-Vitro Diagnostic Devices and 3 years after publication for medical devices. It has been a long process and this agreement is an important step towards finalizing modern medical devices and IVD legislations that identifies the detail nature of medical technologies which contributes to patient safety and facilitates the development of innovative healthcare solutions.
The design and manufacture of devices only not covered in new regulations but also clinical testing, authorization and post-market surveillance .It will have an impact about every device manufacturer that sells products in the European Union and they come as tens of thousands of Europeans suffered over the last ten years from metal-on-metal hip replacements and faulty breast implants.
As the current main regulations for medical devices and IVDs have not been updated since the 1990s, the agreement marks important steps towards improving healthcare for all EU citizens and will be an interesting development to follow in the months and years to come. One can also see changes/new drafts in the Indian market for medical devices. A detailed procedure for registering medical device and In Vitro Diagnostic Devices (IVD) in India can be found in Morulaa blog section.
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