Two new guidelines from European Commission, plus latest consolidated MDR text

The European Commission has published two new guidance documents on its website in addition to making available an up-to-date consolidated version of the Medical Device Regulation (MDR, 2017/745).

The new guidance documents are:

• MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745, and
• Communication from the Commission: Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 2020/C 171/01.

The consolidated version of the MDR, which includes revisions from the two corrigenda and ‘Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions’, can now be accessed from here.