Medical devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Regulation is primarily concerned with enabling patient to access high quality, safe and effective medical devices, and avoiding access to products that are unsafe. When appropriately implemented, regulation ensures […]

To market any healthcare product in a specific country, adhering to discrete country regulations are mandatory. Similar to drugs, medical devices in United States (US) follows various review processes for approval based on their classification. US Food and Drug Administration (FDA) classifies medical devices into three classes’ viz., class I, class II, and class III […]

Mutual Recognition Agreements (MRAs) are trade agreements which prompt two or more countries to accept one another’s conformity assessment certificate. MRAs not only include drugs and Medical devices. It also includes Telecommunication equipment, electromagnetic compatibility, electrical safety, recreational craft, and so on. Advantages: – This trade agreement can have greater impact on international harmonization of […]

Great news for Medtech companies!! Yes. During the December 9th, 2022 session of the Employment, Social policy, Health and Consumer Council (EPSCO) meeting held in Brussels, Belgium. Stella Kyiakides, the European health commissioner announced the postponement of MDR transition deadlines to 2027 for class III and IIb devices and 2028 for lower risk devices such […]

Good news for manufacturers who hold FDA clearance certificate for their medical devices and wants to enter Swiss market. On November 28, the Swiss parliament adopted its national laws, which allows medical devices with FDA approval in to the country. Since 2001, Switzerland had the access to medical devices with EU certificate only. Post adoption, […]

Introduction: The European Commission adopted new regulations in 2017 and they are Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). Main goal of MDR and IVDR is to improve the transparency and data coordination of medical devices distributed and marketed in EU. To accomplish this, European Database for […]

The In Vitro Diagnostic medical devices Regulation (IVDR) will supersede the In Vitro Diagnostic medical devices Directive (98/79/EC) (IVDD). The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on IVDs. […]

FDA charges a particular fee for medical device product review as per federal law. The fee is applicable for various categories of submissions. The appropriate user fees must be paid by the applicant in order for FDA to initiate the review process, unless the applicant is qualified for a waiver or exemption. Payment: Full payment […]

Introduction There are many regulations in European Union (EU) that govern how medical device manufacturers can produce and supply their products. In Europe, there is MDD (Medical Devices Directive) as well as MDR (Medical Device Regulation). The MDR is the successor of MDD and has been put in place to protect the health and safety […]

Post Market Surveillance (PMS) refers to the requirement that manufacturers monitor their medical devices post approval. PMS is a regulatory requirement in significant markets, including the European Union (EU) and the United States (US).  PMS involves reactive data gathering. Manufacturers collect and report adverse events from various resources or databases. These adverse events are either […]

To ensure the safety and efficacy of Medical devices, regulators expect device manufacturers to provide data that accurately reflect the risk profile of the device.  A clinical investigation is defined as a systematic study on human subjects undertaken to assess the performance or safety of a device. Clinical trials for medical devices are conducted predominantly […]

The USFDA have proposed a rule to harmonize 21 CFR 820 to ISO 13485 QMS standard. The alignment of FDA Quality System Regulation (QSR) with ISO 13485 was first proposed in 2018, which would bring United States Quality Management System (QMS) for medical device manufacturers closer in line with quality system requirements in markets such […]

Under IVDD (98/79/EC), 80% of IVDs were permitted to self declare by the manufacturer. The IVDR requires medium to high risk IVDs to undergo reassessment by a notified body. The new concept of classification put forth under IVDR leaves 80% or more IVDs in need of notified body assessment.  Changes to Performance Evaluation Requirements The […]

In vitro diagnostic medical devices are tests conducted on biological samples to find out the condition of a person in regards to specific disease. The range of Invitro Diagnostics (IVDs) are vast, with the radius starting from self-tests for pregnancy and blood glucose tests for diabetics, to sophisticated diagnoses performed in clinical laboratories.  With the […]

There are various treatment options available in the market to treat majority of diseases or serious conditions. However, for few the treatment options are minimal to nil. Keeping this in mind, FDA has formulated a program, known as Breakthrough Device Program (BDP). This is a voluntary program for certain medical devices and device-led combination products […]