The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.
How ready are you for the In Vitro Diagnostic Regulation?
The In-Vitro Diagnostic (IVD) industry is undergoing significant change. The IVD Regulation (2017/746), which replaces the IVD Directive (98/79/EC), entered into force on 25 May 2017. This started the transition period of five years for manufacturers selling IVD devices into Europe.
Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements. BSI is committed to ensuring a smooth transition for all clients wishing to certify to the IVDR.
IVDR Readiness Review
Our interactive Readiness Review can be used to complete a gap analysis of your current documentation and systems against the requirements of the IVDR.
Detail how you intend to meet the new requirements, and list the documents and records that allow you to demonstrate conformity to the Regulation.
Have you classified your device(s) yet? Use our handy Classification Chart to understand which classification devices should fall under.
IVDR Best Practice Guide
Prior to placing a device on the market, manufacturers must undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures.
To minimize delays and reduce the time to certificate decision, we’ve produced the IVDR Documentation Submissions – Best Practices Guidelines.