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EU MDR Implantable Medical Devices

View 379 EU MDR Implantable Medical Devices on BEUDAMED, the Better Database on Medical Devices. Implantable devices are intended to be introduced into the human body and often fall into higher risk classes (IIa, IIb, or III) under the EU MDR, requiring rigorous conformity assessment. Manufacturers must provide comprehensive technical documentation and clinical evidence to demonstrate safety and performance, and higher-risk implantables typically require notified body involvement.

Under EU MDR rules, implantable devices are subject to robust post-market surveillance, vigilance reporting, and Unique Device Identification (UDI) to ensure traceability and timely detection of safety issues. Labeling and patient information must include implant cards and clear instructions for implantation, use, and removal, supporting clinicians and patients in maintaining long-term safety.

Healing abutments S

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·8 devices

Prosthetic screw

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·5 devices

Abutments M, P

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·5 devices

Healing abutments M, P

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·8 devices

Abutments C, CS, B, BS

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·9 devices

Healing abutments C, CS, B, BS

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·2 devices

Dental implant, ROOTT K

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·62 devices

Dental Implant, ROOTT S

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·22 devices

Dental implant, ROOTT BS

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·29 devices

Dental implant, ROOTT B

Basic UDI-DI
EU MDR · Eu Md Class 2b ·TRATE AG·53 devices