Tests on Medical Devices | Regulation (EU) 2017/745

Medical devices, which are intended for diagnostic or therapeutic uses, must comply with strict safety and efficiency requirements.

Specifically, GSPR at Annex I of Regulation (EU) 2017/745  establishes the requirements for safety and performance for CE marking of medical devices for placing on the market and putting into service in the European Union.

Depending on the conformity assessment method chosen by the company, the activities may relate to:

  • Laboratory tests with reference to the harmonised standards applicable to the specific products;
  • Conformity assessments of the medical device technical files;
  • Assessments and monitoring of the Company's Quality Systems, design and manufacturing processes required by the same Directive.

To verify the CE conformity of the devices produced, manufacturers are required to carry out testing activities through bodies authorized by the competent Ministry and notified by the European Community considered to meet the minimum requirements set out in Regulation (EU) 2017/745.

Beyond its regulatory role, MTIC InterCert boasts an accredited laboratory renowned for its proficiency in testing medical devices for electrical safety, electromagnetic compatibility (EMC). As an example:

  • Ultrasound and physiotherapy devices
  • Surgical, cosmetic, therapeutic and diagnostic laser devices
  • Nerve and muscle stimulation devices
  • Electrocardiographs
  • Automatic noninvasive sphygmomanometers and pulse oximeters
  • Medical beds
  • Non-active non-implantable devices for wound and skin treatment
  • For gauze, testing can be done according to FU IX and UNI EN 14079:2004 “Performance requirements and test methods for absorbent cotton gauze and cotton and viscose gauze Absorbent”
  • Devices manufactured by processing metals
  • Devices manufactured by processing plastics
  • Verification of correspondence of materials to data sheets
  • Devices manufactured by processing non-metallic and non-mineral materials, such as textiles, rubber, leather, paper
  • Verification of compliance of materials with Reg 1907/2006 (REACH)

This amalgamation of regulatory expertise and laboratory excellence positions MTIC InterCert at the forefront of ensuring the safety and compliance of medical devices, fostering confidence among manufacturers, healthcare professionals, and patients alike.

Service provided by MTIC InterCert Srl.

Contact our offices in Rho (MI) to request a quote.

t. +39 02 97071800 - m. info@mtic-group.org