Hamm, May 5, 2017
The official version of the Medical Device Regulation was published in the Official Journal today. This publication also applies to the Regulation on Active Implantable Medical Devices. A separate regulation with the same date has been published for In Vitro Diagnostics (IVD). The regulation will come into force after a period of 20 days.
A three-year transition period will then apply to all manufacturers.
The full text can be found on the European website:
VERORDNUNG (EU) 2017/745 DES EUROPÄISCHEN PARLAMENTS UND DES RATES
vom 5. April 2017
über Medizinprodukte, zur Änderung der Richtlinie 2001/83/EG, der Verordnung (EG) Nr. 178/2002 und der Verordnung (EG) Nr. 1223/2009 und zur Aufhebung der Richtlinien 90/385/EWG und 93/42/EWG des Rates.
http://eur-lex.europa.eu/legal-content/DE/TXT/HTML/?uri=OJ:L:2017:117:FULL&from=DE
This regulation, which does not need to be transposed into national law, contains significant changes in Medical Device Law. The changes will result in an enormous amount of work in every Medical Device Company, both in the area of Technical Documentation and in the cooperation with the Notified Body.
We recommend that every company that acts as a manufacturer within the meaning of the directive (currently still) carry out a delta analysis (GAP analysis) for the respective product range in a timely manner and set up appropriate action plans.
In the next few days, we will write a document with the main changes and publish it on our website.
Your WQS Team
