Jun 14, 2016
European lawmakers and regulators have published eagerly awaited draft versions of new medical device and IVD regulations earlier than anticipated.
Emergo consultants in Europe and the US are performing a comprehensive evaluation of the new Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) to determine any significant changes from initial proposed regulatory changes in 2012.
Based on a high-level analysis of the MDR text, shown below are some initial key points. We have a separate overview of the IVDR here.
As previously reported by Emergo, the MDR will come into effect in late 2019 or early 2020. Before implementation, there will be a formal procedure whereby the consolidated regulatory text is translated for all EU member languages, followed by formal publication. After that publication, expected in late 2016 or early 2017, there will be a three-year transition period.
In terms of implications for CE Marking, certificates issued prior to final implementation of the MDR in late 2019 or early 2020 will have a maximum validity of five years. However, all CE Mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force.
The Dutch embassy in Brussels held a meeting to inform major stakeholders about the expected developments regarding negotiations about the new regulations for medical devices and in vitro diagnostics.
As we wrote earlier, European Regulations for Medical Devices and IVDs are still in their “First Reading” stage. In order to come to the formal First Reading document, the European Parliament, the Council and the European Commission are now negotiating under the Dutch EU-presidency.