MDR

On the face of it, this seems simple. Manufacturers can simply self-declare and the Q&A Document states this in section 7. Furthermore, it states that such a self-declaration could be based on a harmonised template. The downfall here is no such thing currently exists. Additional evidence could be provided by Notified Bodies (NB) again by … Read more

The EU have swiftly issued this Q&A document after fast-tracking Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. It’s an interesting document and some will certainly find the information helpful, but in truth, this only clarifies what is … Read more

The much-anticipated amendment regarding the extension of the MDR transitional periods and the removal of the sell-off dates of both MDR and IVDR has entered into force as of 20th March 2023. The amendment was introduced to address the projected shortage of medical devices on the market in the coming years and to address the … Read more

In early January, the EU commission put forward a proposal to extend the transition period for certain medical devices and the removal of the sell-off date for IVDR devices due to concerns of medical device shortages and notified body capacity. In February, the EU parliament has voted by a landslide in favour of the proposal … Read more

The EU Commission has in place a draft implementing regulation, reclassifying certain active products without an medical intended purpose. Certain devices that fall into the category of High intensity electromagnetic radiation emitting equipment without an intended medical purpose are due to be reclassified to ensure an appropriate conformity assessment of those active products is consistent … Read more