Gap analysis is a crucial step for any company seeking EU EUDAMED compliance, as it serves to identify the differences between the company’s current operations and the new regulation. With realizing EUDAMED, manufacturers of medical devices will be required to comply with new regulations and requirements that will have an impact on their operations and […]
CEP/CER, PSUR, and PMCF are essential components of the regulatory compliance requirements for the medical device industry. These regulatory documents are essential for ensuring the safety, efficacy, and quality of medical devices throughout their lifecycle. According to the new EU Medical Device Regulation, the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) are mandatory […]
The Regulation (EU) 2017/745 relating to medical devices, which amends Directive 2001/83 / EC (Community code relating to medicinal products for human use), Regulation (EC) n. 178/2002 (food safety) and regulation (EC) n. 1223/2009 (cosmetics) and repealing directives 90/385 / EEC (active implantable medical devices) and 93/42 / EEC (medical devices), entered into force on […]