Why Do I Need a Medical Device Technical File?

Medical device manufacturers have to comply with strict regulations when selling their products in the EU. Read on to learn more about them!

Medical devices include everything that goes inside the human body, from pacemakers to stents. They're regulated by the European Union (EU) because they contain potentially dangerous chemicals and materials. Manufacturers must follow specific guidelines to ensure safety and effectiveness.

The Medical Device Directive (MDD)The MDD was adopted in 2006 as part of the EU's efforts to harmonize its medical product legislation across member states. It sets out requirements for the design, manufacture, testing, labeling, packaging, distribution, sale, and use of medical devices.

The Medical Device Regulation (MDR)The MDR applies to any "medical device" sold within the European Union. This includes implants, prostheses, orthotics, hearing aids, dentures, surgical instruments, and other items used during surgery.

The European Union Clinical Trials Directive (EUCTDs)The EUCTD was introduced in 2001 as an amendment to the EU Clinical Trials Directive (CED). It requires sponsors of clinical trials involving human subjects to register their trial at the EudraCT database before starting the study.

The Medical Device Safety Report (MDSR)The MDSR is a mandatory report required by law in the European Union. This report must be submitted to the competent authorities within 15 days after the end of each phase of the clinical trial.

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