Blogs

How to place a device in the Northern Ireland market? 

How to place a device in the Northern Ireland market? 

Under certain conditions, the UK MDR 2002 mandates that you notify the MHRA at the time of your device's initial sale in Northern Ireland. The manufacturer's location, the Authorised Representative's location, and the device class determine the specific criteria. ...

UK Medical Device Registration Process

UK Medical Device Registration Process

How to do medical device registration with the Medicines and Healthcare products Regulatory Agency (MHRA)?  The following steps are followed to register a medical device in the UK market as per the news released by MHRA on 10 Jan 2024.   What can be...

Implementation of Medical Devices future Regime

🌐 Exciting News in the Healthcare Sector! 🏥 The UK Government is making significant strides in shaping the future regime for the implementation of medical devices. 🚀 🔬 The commitment to advancing healthcare technology is evident as the government sets the stage for a...

Understanding Borderline Cosmetics in the EU

Understanding Borderline Cosmetics in the EU

Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When...

Establish a Medical Device Startup Company

Establish a Medical Device Startup Company

Medical device startups play an essential role in revolutionising patient care and improving quality of life. If you share our passion for innovation, starting a medical device company could prove rewarding yet challenging – this article offers comprehensive guidance to help get one started.

Software As a Medical Device and Its Clinical Evaluation

Software As a Medical Device and Its Clinical Evaluation

Software as a medical device (SaMD) refers to a class of medical software that performs one or more medical tasks independently of a physical medical device. It can interface with other medical equipment or software or be utilised with non-medical computer platforms like smartphones. It may be used for a number of objectives, including illness detection, diagnosis, treatment, or prevention. The quality of life for patients and providers can be enhanced through its interactions with data. Regulation is necessary for SaMD since it is a novel and creative technology that must be safe.

Technical Documentation Requirements MDD Vs MDR

Technical Documentation Requirements MDD Vs MDR

Check out the difference between MDD vs MDR MDD vs MDR MDD A MDD Technical documentation must include: A general device description, including any information on any planned variants Design drawings, details on the planned method of manufacture, diagram of components,...

Safety Reporting on Clinical investigation

Safety Reporting on Clinical investigation

Under EU MDR 2017/245 Article 73, the sponsor shall report to all member states about the clinical investigations undertaken by the medical devices through an electronic system in case of any serious adverse events, device deficiency which leads to adverse events or...

eSTAR Pilot program by Health Canada & US FDA

eSTAR Pilot program by Health Canada & US FDA

eSTAR (electronic Submission Template and Resource) is an initiative launched by the US Food and Drug Administration in February 2020. It is a free, interactive PDF Form that provides assistance to the applicants in preparing the CDRH medical device submission for...

MDCG Guidance for Manufacturers of Class I Medical Devices

MDCG Guidance for Manufacturers of Class I Medical Devices

This document is intended to serve as guidance for Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union market in order to comply with MDR requirements. This guidance should also apply when an importer, distributor, or any other legal entity takes on the obligations owed by manufacturers.

Post Market Surveillance Plan – FDA

Post Market Surveillance Plan – FDA

Post Market surveillance requirements are set out in Title 21 Code of Federal Regulation (CFR) Part 822. This article aims to put an adequate post-market surveillance authority into practice to increase the possibility that post-market surveillance (PMS) plans will result in valuable data gathering.

Registration of Legacy Devices in EUDAMED

Registration of Legacy Devices in EUDAMED

Legacy Devices are the medical devices covered by a valid Directive certificate under Directive 93/42/EEC or Directive 90/385/EEC and continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR). Those devices should be...

Cosmetics Product Recall under FDA

Cosmetics Product Recall under FDA

Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm's removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and against which the FDA would start legal action, such as...

Vigilance in EU MDR

Vigilance in EU MDR

MDR Vigilance is a strategy for gathering information on post-market adverse medical device incidents. Vigilance System strives to lessen the likelihood of incidents while also increasing patients’, healthcare provider, and other user protection. Chapter VII Section 2 of the EUMDR contains the vigilance requirements (Articles 87 to 92).

EU MDR Market Surveillance Activities

EU MDR Market Surveillance Activities

Market surveillance is the activity carried out by the competent authorities according to Article 93 of MDR 2017/745 to ensure that products on the market comply with the relevant laws and regulations and with the current EU health and safety requirements. Maintaining...

FDA’s Adverse Event Reporting for Cosmetics

FDA’s Adverse Event Reporting for Cosmetics

The FDA keeps an eye on cosmetics sold on the market to make sure people may use them safely. When a consumer, manufacturer, or medical practitioner submits an adverse event report (AER), FDA may learn of a safety concern. Any issue that occurs after using a cosmetic product might be considered an adverse event.

Animal Testing for Cosmetics

Animal Testing for Cosmetics

The term "animal testing" refers to procedures carried out on living animals for research into basic biology and diseases, evaluating the efficacy of new pharmaceuticals, and testing the safety of consumer and industry products such as cosmetics, household cleaners,...

Manual on Borderline and Classification of Medical Devices

Manual on Borderline and Classification of Medical Devices

A manual on borderline products has been released by the Medical Device Coordination Group (MDCG), an advisory group of the European Commission in charge of the regulatory framework for medical devices. The method to determine a product’s regulatory status when it is questionable is thoroughly described in the document. The guidance, in particular, specifies the elements to be taken into account when reaching such a conclusion and offers recommendations.

EU Notified Body

EU Notified Body

A notified body is an independent organisation designated by an EU country to assess the conformity of products before being placed on the market. Under EU MDR 2017/745, the notified body is also called a conformity assessment body.   A conformity assessment body...

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation in the EU MDR

Manufacturers must plan, carry out, and document a Clinical Evaluation in order to comply with the general safety and performance standards outlined in Annex I, as per Article 61. Clinical evaluation is a series of ongoing activities that use scientifically reliable techniques for the evaluation and analysis of clinical data in order to confirm the safety, clinical performance, and/or effectiveness of the medical device when used in accordance with the manufacturer’s instructions.

Risk Management of medical devices under MDR

Risk Management of medical devices under MDR

All medical devices are associated with inherent risks of some level. It is imperative to understand the medical device's specific risks to a patient. Under EU MDR 2017/745, risk management is a continuous and iterative process. Manufacturers are expected to plan,...

Cybersecurity for medical devices in Europe

Cybersecurity for medical devices in Europe

Cybersecurity for Medical devices is advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. With the advancement of software as a medical device, proper regulations must establish the safety and security of medical devices.

IMDRF Regulation on SaMD

IMDRF Regulation on SaMD

IMDRF Regulation on SaMD: As more businesses see the benefits of utilizing their software development knowledge for the benefit of patients throughout the world, the market for software as a medical device (SaMD) is expanding quickly.

Health Canada Medical Device Listing

Health Canada Medical Device Listing

Health Canada is the regulator of therapeutic products, including medical devices. Health Canada’s Medical Devices Active Licencing listing (MDALL) contains a list of products that are already in the Canadian medical device market. It also contains the database for products that were previously licensed.

Smart Wearables Regulations in the EU 

Smart Wearables Regulations in the EU 

Smart wearables technology is gearing up to great potential and becoming a part of our daily lifestyle. While most of them are claimed to fall under general wellness equipment, there is a rising concern about how these devices are regulated in terms of safety without falling under the stringent medical device regulations.

CDSCO Registration Process

CDSCO Registration Process

The Indian Medical Device Rules regulatory have transformed to be more complicated over the years. The Central Drug Standard Control Organization (CDSCO) regulates medical devices and In-Vitro Diagnostics (IVD) marketed in India. The main official body that is responsible for the approval of the manufacture, import, sale, and distribution of medical devices is the Drug & Cosmetic Act and Rules (DCA).

De Novo Request | FDA

De Novo Request | FDA

The De Novo request provides a marketing pathway to classify novel medical devices for which general controls, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.

Quality Management System Requirements of EU MDR

Quality Management System Requirements of EU MDR

The quality management system shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures, and devices. It shall govern the structure, responsibilities, procedures, processes, and management resources required to implement the principles and actions necessary to comply with EU MDR 2017/745.

Corrective And Preventive Action (CAPA)

Corrective And Preventive Action (CAPA)

Corrective Action and Preventive Action, or CAPA, is a systematic approach for discovering the root cause of problems and methods to resolve them. CAPA is a mandatory compliance procedure across organisations implementing a Quality Management System (QMS). For any QMS, it is essential to identify the root cause of the problem , take corrective action and prevent the same issue from recurring. This is the objective of CAPA.