Medical Devices
Medical device manufacturers in Europe seeking to enter the Romania market must comply with EU MDR 2017/745 and demonstrate conformity through comprehensive technical documentation. National Agency for Medicines and Medical Devices oversees medical device regulation in Romania, requiring manufacturers to establish proper representation and meet stringent safety and performance requirements.
Taylored Consultancy provides complete medical device regulatory support for Europe companies expanding to Romania. Our services include device classification, technical file preparation, clinical evaluation, UK Responsible Person (UKRP) or EC Representative (EC-REP) services, and ongoing post-market surveillance to ensure full compliance throughout your product lifecycle.
Full conformity assessment under European Medical Device Regulation, classification determination, and technical file preparation for Romania market authorization.
Risk classification (Class I, IIa, IIb, III) determination and appropriate conformity assessment route selection based on device intended purpose and risk profile.
We act as your mandatory EU-established EC Representative (EC-REP), handling notifications, maintaining technical files, and liaising with National Agency for Medicines and Medical Devices.
Complete technical file preparation meeting MDR Annex II/III requirements, including design dossiers, clinical evaluation, risk management, and post-market surveillance plans.
CE marking affixing process, European Database on Medical Devices (EUDAMED) registration, and Unique Device Identification (UDI) system compliance for Romania.
Notified Body selection, application support, and conformity assessment management for Class IIa, IIb, and III devices requiring third-party verification.
