PEPGRA HEALTHCARE Private Limited

The term medical devices cover a wide range of medical equipment from common tongue depressors to highly sophisticated surgical and advanced diagnostic equipment that are used in various specialized medical disciplines. These different types of equipment are extensively used in various sized hospitals ranging from rural health clinics to multi-specialty hospitals providing tertiary patient care. Similar to medicines and medical technologies, the medical devices are also highly essential for maintaining proper patient care. In this era of liberalization, medical devices are commonly imported in developing countries, which potentially increase the chances of unscrupulous commercial elements causing significant concerns for the safety of patients on whom the inferior quality devices are used. To avoid this, all the main countries have established or follow global standard regulatory control  guidelines for medical devices  to prevent the use of substandard equipment, thereby minimi

Biological Safety Assessment  or  BSA  as it is called is an important and wide field. As new breakthroughs by way of medicine, crop, biotechnology increase, the need to assess the safety of medical devices becomes paramount. It provides some amount of reassurance to patients in a clinical investigation. A report should be based on medical devices directives -MEDDV 2.7.1 and clinical investigations guidelines ISO 14155. Writing a Biological Safety Assessment (BSA) report  can run as under: 1  Clinical data and Evaluation and Evidence : The safety and/or performance information that is generated from the clinical use of a device and a procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device and an evaluation report pertaining to the medical device.

Within the medical devices industry, professionals have long been exercising acquiescence with regards to the new European  Medical Device Regulation  (MDR). At last, after a very lengthy process the MDR was finalized and it was duly published in the Official Journal of the European Union on 5th May, 2017.             With the passing of the new MDR, the previous regulations viz., the Active Implantable Medical Device Directive (90/385/EEC) as well as the Medical Device Directive has been totally replaced. The primary objective of the Revision of Medical Device Regulation is to ensure a  regulatory framework  that is sustainable, forceful, foreseeable and clear which is essential for ensuring that the level of safety is extremely high within the healthcare sector and at the same time fosters innovation Guidance to  Medical Device Regulations in Europe To highlight the key modifications that have been effected by the new MDR and to resolve these issues, the top five hurdl