The previously approved regulation -stating that the MDR deadline will be extended, has now entered into force. Along with the news, it became official that "devices which have a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC (...)" may be placed on the market or put into service until 31 December 2027 or 31 December 2028, depending on the risk factor.
Even though the approved regulation gives the manufacturers more time to meet the legal requirements, it is worth starting to prepare for the changeover now.
The medical division of QTICS Group is happy to provide you any kind of support throughout the conformity process.
medical@qtics.group
www.qtics.group
In the meantime we created a short summary about the most important facts regarding the MDR deadlines.