Guidance document for class I device manufacturers

The Medical Device Coordination Group (MDCG) issued a guidance document to help manufacturers of class I medical devices to comply with Regulation (EU) 2017/745 on medical devices (MDR). 

It gives a general overview of the overall requirements that are applicable for these types of devices and also explains which aspects manufacturers should consider. The document addresses specific issues like the General Safety and Performance Requirements and the preparation of technical files.

From a first review it is more or less in line with the recommendations mdi Europa has communicated over the past. And although the document may not answer each and every question, we highly recommend to review the guidance. It should be carefully read and interpreted in conjunction with the corresponding MDR sections. 

Source: MDCG guidance document

We recommend the following sources for in depth information

Browse our website by keyword. 
Visit our corresponding Download Section regarding MDR.
Read our article “Technical Documentation Requirements under the MDR – a Case Study”.
Visit our page “Major Aspects of the MDR“.
Visit our page “Major Aspects of the IVDR“.