EU MEDICAL DEVICE REGULATION: KEY CHANGES AND CHALLENGES

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With the advancement of the technologies and innovation in the medical device developments, the difference in the interpretation of the existing Directives, as well as the breast implant crisis, highlighted weaknesses in the legal system and which creates a growing need to regulate the MedTech Industry. New Medical Device Regulation (EU) 2017/745 and (EU) 2017/746 replaced the existing three Directives (90/385/EEC, 93/42/EEC, and 98/79/EC). The MDR key changes include medical device reclassification, the guideline on the reprocessing of single-use devices, updates on the market access of legacy products, more requirements on technical documentation, clinical evaluation, vigilance, and PMS activity, and entry of UDI System. To satisfy the MDR requirements, companies especially small and medium-sized medical technology companies face considerable difficulties. The companies are facing challenges with time like short transition timeline, lack of expertise, inadequate resourcing and development of standard operating procedure (SOP’s) to comply with MDR essential requirements.

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Author Profile

Shivappa Somaning Hinchageri

Specialist, Medical Writing, Pharmacovigilance at FMD K&L Inc

He is a medical writing professional having 8 years of work experience in Clinical Research, Pharmacovigilance and Clinical Evaluation Report Writing for Medical Devices and Diagnostics. Prior to joining FMD K&L, he worked with prolific companies like Accenture and Cognizant Technology Solutions as Senior analyst.