The most important numbers of the year: 2017/745 – 336 - 1095
2017/745 is the name of the MDR as a guideline
336 pages must now be read and edited
1095 days are available for full implementation
It's published! On 05.05. in 2017, the MDR was adopted in Brussels, which enters into force on 25.05.2017. So at the end of the month, the three-year transitional period will run.
The original text can be found here.
More information here.
Many of the changes have been incorporated into the regulatory and auditing practice of Notified Bodies in recent months and years. For instance in ISO 13485: 2016 in quality management and MEDDEV 2.7.1 Rev.4 in the area of clinical evaluations.
What changes will happen over the coming years to the manufacturers is the subject of investigation in the working group "CE Documentation" of the Association Life Science Nord e.V., moderated by Qualitätsplan.
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