Blogs

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...

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.

FDA’s 510(K) Submission Process 

FDA’s 510(K) Submission Process 

A 510(K) formally known as the Pre-market notification required by the U.S Food and Drug Administration to market medical devices in the U.S geography. The main goal of the 510K submission is to demonstrate that the device to be marketed is safe and effective. The device in question should be a “substantial equivalent” to a predicate device (a predicate device is an existing device which is legally marketed in the U.S).
We will discuss the complete FDA 510(K) submission process in this article.

EU MDR – Article 117

EU MDR – Article 117

EU MDR’s Article 117, is a very short article, but with a great impact on the procedures for marketing medicinal products integrated with medical devices.

MDCG Guidance on Article 110(3) of the IVDR

MDCG Guidance on Article 110(3) of the IVDR

MDCG Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR aims to provide clarification on the concept of ‘significant changes in the design and intended purpose’. This article applies to manufacturers of devices that comply with Directive 98/79/EC and are placed on the market or put into operation after the transition period ends on May 26, 2022 irrespective of the involvement of notified body under the IVDD.

Nomenclature of medical devices

Nomenclature of medical devices

‘Medical devices’ is an umbrella term that includes products for the prevention, diagnosis, and treatment of numerous diseases. Medical devices require an internationally accepted naming to identify the various types and categories. Nomenclature of medical devices helps understand the medical device’s risk class, definition, and use.

Current Good Manufacturing Practices (cGMPs) of the FDA

Current Good Manufacturing Practices (cGMPs) of the FDA

The cGMP standards ensure products’ identity, strength, quality, and purity by requiring manufacturers to maintain proper control over their manufacturing processes. The “C” in cGMP refers to “Current,” which means that organisations must employ up-to-date technologies and systems to comply with the rules.

Labelling and IFU requirements of the New EU IVDR

Labelling and IFU requirements of the New EU IVDR

Each in-vitro diagnostic medical device must be accompanied by the information necessary to identify the device and its manufacturer and any safety and performance information relevant to the user or any other person. Significant changes brought in EU IVDR from EU IVDD in terms of labelling and Information for use (IFU) requirements are discussed in this article. By 26 May 2022, the IVDR Regulation 2017/745 will be in full effect.

Updates in ANVISA GMP 2022 document 

Updates in ANVISA GMP 2022 document 

The Good manufacturing practices (GMP) document released on 30th March 2022 for Medical and IVD products replaced the GMP document released by ANVISA in 2013. In this article we will discuss the Significant changes that were made in the latest 2022 Regulations which supersedes the 2013 version.

Guidance On Class I Medical Devices

Guidance On Class I Medical Devices

Before marketing their medical devices in Europe, manufacturers must comply with EU Medical Device Regulations (EU MDR 2017/745). MDR ensures that manufacturers meet specific regulatory requirements, and manufacturers of Class I are not exempted from these. This article provides guidance for Class I medical device manufacturers.

Annex XVI – EU MDR

Annex XVI – EU MDR

The new Medical Devices Regulation (MDR), which came into effect on May 25, 2017, controls some kinds of devices that are not designed for medical use and are categorised in Annex XVI. These products, like all other medical devices, are required to comply with the MDR’s obligations by the 26th of May 2020.

SaMD Devices Classification

SaMD Devices Classification

SaMD is software intended for one or more medical purposes that perform these without being part of a hardware medical device. Medical device software is meant to be used, alone or in combination, for a purpose specified in the definition of a “medical device” in the...

Field Safety Corrective Action (FSCA) – Swiss

Field Safety Corrective Action (FSCA) – Swiss

What is a Field Safety Corrective Action? Any action performed to reduce the risk of death or serious deterioration in health connected with the use of a medical device is referred to as Field Safety Corrective Action. The manufacturer is required to take action to...

Regulatory Pathway for Clinical Investigation In the UK

Regulatory Pathway for Clinical Investigation In the UK

Clinical Investigation of medical devices follows a different regulatory pathway. A clinical investigation is a systematic study of one or more humans to evaluate a medical device’s safety, clinical performance, and overall effectiveness. Clinical investigation plays a massive role in patient safety. This article is based on the document on Notification of MHRA about a clinical investigation for a medical device.

Regulatory Pathway for Clinical Investigation in the EU

Regulatory Pathway for Clinical Investigation in the EU

Clinical Investigation of medical devices follows a different regulatory pathway. A clinical investigation is a systematic study of one or more humans to evaluate a medical device’s safety, clinical performance, and overall effectiveness. Clinical investigation plays a massive role in patient safety. The information regarding this article is taken from the guidance documents released by the Medical Device Coordination Group (MDCG).

EU Classification of Medical Devices with examples

EU Classification of Medical Devices with examples

Classification of Medical Devices Around the world, the definition of medical devices varies. Still, generally, a medical device is any instrument, equipment, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related...

LEGACY MEDICAL DEVICES REQUIREMENTS IN EUROPE

LEGACY MEDICAL DEVICES REQUIREMENTS IN EUROPE

Legacy devices include all previously regulated devices under the Medical Devices Directives (MDD 93/42/EEC 90/385/EEC) and In-vitro Diagnostic Devices Directive (IVDD 98/79/EC). Medical Device Coordination Group (MDCG) published the guidance documents on the...

Field Safety Corrective Action (FSCA) – US FDA

Field Safety Corrective Action (FSCA) – US FDA

What is Medical Device Reporting? Medical Device Reporting (MDR) is one of the FDA's post-market surveillance techniques for monitoring device performance, detecting potential device-related safety concerns, and contributing to device benefit-risk assessments. There...

SaMD Device Regulation (UK & Europe)

SaMD Device Regulation (UK & Europe)

Under both the EU MDR and the EU IVDR, the MDCG rules specify the conditions for a product to qualify as medical device software (MDSW). An MDSW product can enter the market in one of the ways:   As a standalone medical device or  As a component of another...

UDI DI

UDI DI

UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally introduced the UDI system in the EU. The UDI comprises the following components A device identifier (UDI-DI)A production identifier (UDI-PI) The Basic...

EU Requirements for Translations

EU Requirements for Translations

Under the Medical Devices Directive (MDD), it is required that manufacturers have translations of the technical documents like Instructions for Use. However, this rule wasn't strictly followed up until MDR was brought in place. The European Union's language...

Electronic Instructions For Use Of Medical Devices

Electronic Instructions For Use Of Medical Devices

Commission Regulation (EU) No 207/2012 on electronic instructions for use of medical devices was published on 9 March 2012 and came into effect on 1 March 2013. There are 10 articles in this regulation. It establishes certain requirements for the “instructions for...

Implant Card for Switzerland

Implant Card for Switzerland

Implant Cards in Switzerland For implantable products, the manufacturer must provide the product information required under Article 16 of MedDO, the information required under Article 18 paragraph 1 EU-MDR and must include the implant card. In Switzerland, the implant...

Implant Card for Europe

Implant Card for Europe

The European Union’s Medical Device Regulation (MDR 2017/745) introduces a new requirement for manufacturers producing implantable medical devices. As per MDR, implantable devices are any devices, other than the active implantable devices, that are partially or...

ISO 15223-1: 2016

ISO 15223-1: 2016

Many countries demand that medical devices provide textual information in their local language. When different languages are incorporated on a single label or piece of paperwork, this can cause issues with translation, design, and logistics. Users of medical devices...

Different Levels Of Labelling

Different Levels Of Labelling

The different levels of labelling are related to the different levels of packaging. There are 3 levels of packaging which corresponds to the levels of labelling. They are: Primary Packaging The Primary packaging is the packaging that most closely touches a product and...

UK Declaration of Conformity

UK Declaration of Conformity

After Britain leaving the EU, there have been many changes in the regulations regarding medical devices. An example of this is the UK’s Declaration of Conformity.UK Declaration of Conformity (DoC) is a technical document that products with UKCA marking should possess....