Post the Brexit scenario, the Regulatory landscape for medical devices in the United Kingdom (UK) underwent a profound metamorphosis, significantly impacting manufacturers aiming to introduce their products. As the UK made an exit from the European Union (EU), there was a shift from Conformité Européenne (CE) marking to UK Conformity Assessed (UKCA) marking. However, presently, the Medicines and Healthcare products Regulatory Agency (MHRA) still allows the placing of CE-marked devices on the UK market.

Introduction

The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.

Medical device grouping in India is a Regulatory process that enables manufacturers and importers to register multiple devices under a single license. Regulated by the Central Drugs Standard Control Organization (CDSCO), the grouping guidelines specify how companies can group their medical devices for import or manufacture clearance. This classification simplifies the application process and saves time and costs for license applicants.

In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions. The European Union's In Vitro Diagnostic Regulation (IVDR) 2017/746 introduced a new classification system for IVDs.

Literature reviews play a crucial role in the clinical evaluation of medical devices and In Vitro Diagnostics (IVDs) throughout their entire lifecycle. These reviews enable researchers to examine previous studies, build upon existing knowledge, and contribute meaningfully to their respective fields. However, adhering to traditional approaches in a literature review can be time-consuming and arduous, particularly considering the evolving needs and demands of the medical field. This can lead to missed opportunities and incomplete analysis.

With the transition in the European Union (EU) geography, from the Directives to the EU Medical Devices Regulations (MDR) 2017/745, significant changes have occurred in terms of rules and regulations. One such major change was observed in Annex I – General Safety and Performance Requirements (GSPR). In our previous blog, we deep dived into Chapter I and II. In this blog, we will analyze Chapter III and learn about additional details and Essential Requirements (ERs).

IVD devices are essential for healthcare professionals in providing accurate and timely diagnosis, monitoring, and treatment of diseases, leading to improved patient outcomes and better public health. IVD devices are classified into different classes based on their level of risk to the patient and the complexity of the device. The classification system for IVD devices varies depending on the region or country.

In a global marketplace with more than 7,100 spoken languages, manufacturers need to consider the local language and culture when developing medical device product labels. How does one make it possible to reach out to a diverse group of people?

One of the time-tested ways is the use of medical device symbols. It can convey a significant amount of information in a small space. Although it is optional, using symbols on the labeling of medical devices is strongly advised. It offers benefits to both users and manufacturers, such as:

Globally, the Health Agencies require foreign medical devices and IVD manufacturers to appoint a local representative. In Japan, under the revised Pharmaceuticals and Medical Device (PMD) Act, the In-Country Caretaker (ICC) system was replaced with Marketing Authorization Holder (MAH) system. Under this system, companies shall obtain a MAH license to get the device approval and market the devices in Japan.