Delay proposed for new Medical Device Regulations

12 May 2020

The European Parliament has adopted a proposal to postpone the full implementation of the Medical Device Regulation (MDR) 2017/745 for one year to allow relevant parties to prioritise the fight against the coronavirus pandemic.

The EU MDR 2017/745 was meant to come into force on May 26 to ensure better protection of public health and patient safety for certain products without an intended medical purpose. Listed under Annex XVI, the new MDR will regulate certain groups of products which a manufacturer claims only has an aesthetic or another non-medical purpose, but which are similar to medical devices in terms of functioning and risk profile. 

These include dermal fillers, body sculpting equipment and intense pulsed light (IPL) machines for body hair removal. The proposal needs to be approved by the member states and published in the Official Journal of the European Union before it will enter into force, which is expected to be by 26 May 2020. 

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