Urgent­ly Required MDR Guid­ance Doc­u­ments for Clin­i­cal Eval­u­a­tions and PMCF Published

The Euro­pean Com­mis­sion seem­ing­ly wants to catch up with the short­falls of the last years. Late April, the fol­low­ing guid­ance doc­u­ments for Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) have been pub­lished. Please review care­ful­ly as they may be impor­tant for your tran­si­tion, espe­cial­ly regard­ing clin­i­cal evaluations:

• MDCG 2020-5
  Clin­i­cal Eval­u­a­tion – Equivalence

• MDCG 2020-6
  Reg­u­la­tion (EU) 2017/745: Clin­i­cal evi­dence need­ed for med­ical devices pre­vi­ous­ly CE marked under Direc­tives 93/42/EEC or 90/385/EEC

• MDCG 2020-7
  Post-mar­ket clin­i­cal fol­low-up (PMCF) Plan Template

• MDCG 2020-8
  Post-mar­ket clin­i­cal fol­low-up (PMCF) Eval­u­a­tion Report Template

Fur­ther­more, in the course of the COVID-19 cri­sis, the Com­mis­sion has issued guid­ance on cer­tain prod­uct types that are urgent­ly required in the giv­en situation:

• MDCG 2020-9
  REGULATORY REQUIREMENTS FOR VENTILATORS AND RELATED ACCESSORIES

It is a chal­leng­ing time, which makes it dif­fi­cult to keep track with all devel­op­ments. Should you have any ques­tions, please don’t hes­i­tate to get in touch.

Sources: MDCG guid­ance documents

In order to receive more infor­ma­tions on Guid­ance Doc­u­ments you might chose from the fol­low­ing options

• Browse our web­site by key­word guid­ance doc­u­ments.
• Vis­it our Com­plete Down­load Section.
• Read our para­graph “Major aspects of the MDR”.
• Read our arti­cle “Most impor­tant changes on MDR“.
• Read our arti­cle “MDR and IVDR Guid­ance Updates“.
• Read our arti­cle “Lat­est MDCG Pre­pared­ness Plan and MDR Delay“.