The European Parliament has endorsed the new Regulation on In Vitro Diagnostics (IVDR), a development welcomed by the British In Vitro Diagnostics Association (BIVDA).
A final vote was cast today (5 April 2017), bringing an eight year process to update the legislation, to its conclusion. The Regulation will be applicable to all IVD manufacturers who place their products within the European Economic Area and reflects the technological and scientific advances made since the implementation of the original IVD Directive (IVDD) 98/79/EC.
Commenting on the result, BIVDA’s Chief Executive Doris-Ann Williams MBE said:
“We are pleased that the European Parliament has endorsed the IVDR, which has been developed to further strengthen patient safety. There will be a considerable additional cost burden to the IVD industry to comply with this Regulation. However, the long development process to produce this Regulation has led to much uncertainty among IVD Manufacturers and we look forward to moving forward once it is published”.
BIVDA’s Chairman, Dr Simon Richards (Alere) added:
“BIVDA has been keeping members informed during the legislative process, and we will continue to work with industry to ensure that companies are fully prepared to meet the requirements of the new Regulation”.
The official timings for transition start 20 days after the Regulation is published in the Official Journal. This is expected in early May, with an official transition starting date anticipated to start around June 1st. Following this, companies will have a five-year period to transition to compliance with the IVDR.
Notes to Editor:
BIVDA is the industry association for manufacturers and suppliers of IVD tests. We represent over 100 members, ranging from British start-up companies to UK subsidiaries of multinational corporations. BIVDA member companies employ more than 8,000 people in the UK, with total industry sales to the NHS of approximately £900 million.
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