EU MDR Implementation

EU MDR Implementation

With the new regulations in the European Union (EU), our expert team of medical researchers and writers can assist you with this transition. We have extensive experience generating regulatory compliant documents for the EU, including:

• Clinical Evaluation Reports (CERs)
• Performance Evaluation Reports for IVDs (PERs)
• Safety and Performance Assessments
• State of the Art Reviews
• Post-Market Surveillance Reports
• Post-Market Clinical Follow-Up Plans and Reports
• Remediation Services

Our documents adhere to the latest guidelines and regulations including:

• Clinical Evaluation: A guide for manufacturers and notified bodies under Directives 93/42/EEC and 90/385/EEC (MEDDEV 2.7/1 revision 4)
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Regulation (EU) 2017/746 of the European Parliament and of the council of 5 April 2017 on in vitro diagnostic medical devices and repealing directive 98/79/EC and commission decision 2010/227/EU