Abstract

NEW EUROPEAN REGULATORY REQUIREMENTS TO GET A CE MARK FOR PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER

Haritha A.* and Pooja Agarwal

ABSTRACT

Cardiac diseases are now being subject to many lifestyle disorders, obesity and stress leading the cause. Diagnosis and treatment of Atrial block to increase life expectancy is possible through sophisticated medical devices including Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter used for pre and post-operative procedures. European Commission has brought about amendments to its previous directives concerning to medical devices, now merged under the Medical device regulations adding in more life cycle approaches to monitor the safety and performance of medical devices, shifting the focus of healthcare industries to establish marketing and manufacturing sectors in the regions under the European Commission. The stringent and aesthetic requirements in the new medical device regulations makes the end product reach an up scaled and more demanding one, this has made, obtaining a European Conformity (CE) certification for medical device under the present new regulations a privilege to leading healthcare business world.

Keywords: Percutaneous Transluminal Coronary Angioplasty Catheter, European Commission, Medical Device Regulations, European Conformity.