The European Commission established nine more harmonized standards for medical devices, increasing the total number of harmonized standards to 14, which device manufacturers can use to meet conformity obligations under MDR .
FREMONT, CA: The European Commission officially acknowledged nine harmonized standards for medical devices, which device manufacturers can use to meet conformity obligations under the Medical Devices Regulation (MDR). The standards address a variety of subjects, including biological evaluation of medical devices, sterilization, aseptic processing, quality management systems, and the use of symbols in the product information. The nine new harmonized standards join an earlier batch of five standards certified by the commission in July 2021, increasing the total number of harmonized standards to 14. The standards were recognized in response to the Commission's appeal to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) to modify and draft standards to support the new regulations.
According to the Commission, detailed technical specifications in relation to the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746 should also be included in the harmonized standards, particularly with regard to device design and manufacture, risk management, and the obligations on economic operators and sponsors, including those relating to quality management systems, risk management, clinical investigations and performance studies, and clinical evaluation and monitoring. These standards should also clearly describe the link between the technical standards and the requirements they intend to address.
The Medical Device Coordination Group (MDCG) explains in a guidance on medical device standardization that harmonized standards generally allow manufacturers and other sectoral actors that also includes notified bodies and national competent authorities) to make easier, faster, and less burdensome the processes related to conformity assessment procedures, affixing of the CE marking and placing on the market, market surveillance, and market surveillance. As the standards are used voluntarily, the manufacturer may always choose to apply the technical solutions provided by harmonized or non-harmonized European standards cited or not in the OJEA, or by any other national or international standards, or as well as to even develop its own technical solutions, provided that it is able to demonstrate that these different or alternative non-harmonized means are adequate.