New guid­ance doc­u­ments pub­lished by the Euro­pean Commission

The date of appli­ca­tion of Reg­u­la­tion (EU) 2017/745 on med­ical devices (MDR) is approach­ing and the Euro­pean Com­mis­sion has issued new and updat­ed guid­ance doc­u­ments. Please find below a list of the cor­re­spond­ing papers.

• Fact­sheet for Class I Med­ical Devices – What You Need to Know About Reg­u­la­tion (EU) 2017/745
• MDCG 2021-5 – Guid­ance on stan­dard­i­s­a­tion for med­ical devices
• MDCG 2021-6 – Reg­u­la­tion (EU) 2017/745 – Ques­tions & Answers regard­ing clin­i­cal investigation 
• MDCG 2018-1 Rev.4 – Guid­ance on BASIC UDI-DI and changes to UDI-DI

Fur­ther­more, please note that the Com­mis­sion has pub­lished the first release of the Euro­pean Med­ical Device Nomen­cla­ture (EMDN) sys­tem. The EMDN codes are based on the Ital­ian CND sys­tem. Infor­ma­tion can be accessed under the fol­low­ing link:

Euro­pean Med­ical Device Nomen­cla­ture (EMDN)

The afore­men­tioned doc­u­ments may either be accessed in our library sec­tion or sent upon request.

Source: Euro­pean Commission

For fur­ther knowl­edge on this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

Arti­cles and pages tagged „Guid­ance Documents“