Medical Device Regulation in Romania
Romania regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745) as an EU member state. The National Agency for Medicines and Medical Devices (ANMDMR) is the national competent authority. Romania has a growing medical device market and aligns its regulatory framework fully with EU requirements.
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Device Classification
Romania follows the EU MDR Annex VIII classification system. Class I includes low-risk devices such as bandages and manual surgical instruments. Class IIa includes medium-risk devices like surgical sutures and ultrasound diagnostic devices. Class IIb includes higher-risk devices such as infant incubators and X-ray equipment. Class III includes the highest-risk devices such as prosthetic heart valves and spinal disc replacements.
Official classification guidance →Standards & Key Principles
Applicable Standards
Key Principles
- CE marking is mandatory for all medical devices placed on the Romanian market under EU MDR 2017/745.
- Economic operators must register with ANMDMR before placing devices on the market.
- Romanian language labeling and instructions for use are required for devices used by lay persons.
- Clinical investigations conducted in Romania require ANMDMR authorization and ethics committee approval.
- UDI requirements follow EU MDR timelines.
Pre-Market Requirements
Manufacturers must undergo conformity assessment per EU MDR requirements. Notified Body involvement is required for Class IIa, IIb, and III devices.
All medical devices must bear the CE mark before being placed on the Romanian market.
Manufacturers and economic operators must notify ANMDMR of devices placed on the Romanian market.
Comprehensive technical documentation per EU MDR Annexes II and III must be prepared, including clinical evaluation and risk management data.
Post-Market Requirements
Manufacturers must maintain PMS systems in compliance with EU MDR Chapter VII to monitor device safety and performance.
Serious incidents and field safety corrective actions must be reported to ANMDMR in accordance with EU MDR requirements.
PSURs are required for Class IIa, IIb, and III devices, with summaries of benefit-risk assessments and PMS findings.
International Recognition & Reliance
As an EU member state, Romania recognizes CE-marked devices certified by any EU-designated Notified Body under the EU MDR.