Medical Devices are an essential element of healthcare by helping to diagnose, treat, monitor or alleviate medical conditions. They include a wide range of products, from everyday products like bandages to complex technologies like heart implants.
In the European Union (EU), Medical Devices are regulated under the Medical Device Regulation (MDR), a comprehensive and harmonized framework designed to ensure safety, performance, and clinical benefit for patients. These regulations are often seen as more adaptable to the diversity and fast-paced innovation of the Medical Device Industry than the U.S. FDA approval system.
Medical Devices have to pass a conformity assessment to ensure that they comply with the applicable regulations. This includes testing the safety, performance and quality of the product according to the applicable standards. After successfully passing the assessment, the products receive the CE marking, which confirms that they comply with the EU Directives.
Their safety is monitored through a Vigilance System. Manufacturers, distributors and healthcare professionals are required to report adverse events and incidents related to Medical Devices. This information is analyzed to identify potential risks and take appropriate action to ensure patient safety.
In contrast to the centralized U.S. system, the European model relies on Notified Bodies – independent organizations that are designated to assess the conformity of products. This decentralized model allows for faster access to the market and encourages continuous improvement. But despite getting started faster, safety remains the top priority. In fact, the EU has introduced even stricter rules with the new MDR, increasing transparency and Post-Market Surveillance.
For the purposes of this Regulation, the following definitions apply:
„Medical Device“ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be placed in the human body, whether alone or in combination, to fulfill one or more of the following specific medical purposes:
Diagnosis, Monitoring, Treatment, Palliation of or Compensation for Injuries or Disabilities;
Study, Replacement or Modification of the Anatomy or of a Physiological or Pathological Process or State;
Obtaining Information by the in Vitro Examination of Samples derived from the Human Body, including from Organ, Blood and Tissue Donations
and which is intended to be administered to or used in the Human Body, but does not achieve its principal intended action in or on the Human Body by pharmacological, immunological or metabolic means, although its action may be assisted by such means.
Importantly, Medical Devices are not drugs. While drugs work chemically, metabolically and immunologically, Medical Devices work mechanically, physically or thermally on the body. For more information, see the page Distinction between Drugs and Medical Devices.
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
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