Technical Documentation Requirements 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, sub-assemblies, circuits etc Descriptions and...
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 (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
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 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
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
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
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 IVDR’s First certification for the type of IVD and Notified bodies procedures
The first certification for the type of device means that the device has no similar intended use with the products placed under the EU market.
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...
MDCG 2022-16 Guidance for Authorised Representatives (AR)
Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations and responsibilities for the Authorised Representative (AR). Key points are taken in accordance with...
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
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
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.
The combination of medical devices and medicinal products based on MDCG 2022-5
Borderline medical products are the products which are a combination of medical devices and medicinal products which are intended to treat, prevent, diagnose diseases, or change physiological function.
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...
MHRA Guidance on Stand-alone Software Medical Devices
Medical device apps are increasingly growing these days. MHRA has issued new guidance on the stand-alone software medical devices, including apps. This guidance is a crucial document for manufacturers and users of such medical devices.
IMDRF guide on Post Market Clinical Follow-up Studies (PMCF)
PMCF is a continuous process that updates the manufacturers’ clinical evaluation during the Post-market surveillance. They must collect user feedback, clinical data, and all other clinical experiences.
Product Liability Insurance for Medical devices
Medical devices are subject to product defects. These product defects arise due to design, manufacturing or even a failed instruction. These defects can cause risks to patient, and they can in turn sue the manufacturer for this.
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.
MEDDEV Guidelines for Clinical Evaluation EU MDR
During the conformity assessment, the manufacturer must submit the complete information material (labelling, IFU (Instructions for Use), any promotional materials and other relevant documents), Clinical evaluation plan & report with the available clinical data,...
The ‘Blue Guide’ on EU product rules implementation 2022
The amended ‘Blue Guide’ on the application of the product rules 2022’ (“Blue Guide”) was released by the European Commission on June 29, 2022. The Blue Guide allows a better understanding of EU product regulations and their uniform and coherent application across...
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 – FDA and EU MDR Perspective
Medical devices and the software of those devices are connected to several types of networks. Therefore, it is particularly important for manufacturers to consider Cybersecurity at the initial stages of the development.
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: 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 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.
Testing Standard Requirements around the World
Medical device testing- an overview Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and...
Requirements of Technical Documentation EU MDR
The technical documentation shall be presented in a clear, organised, readily searchable and unambiguous manner. It shall include all the elements listed in Annex II of EU MDR.
Exceptional Use Medical Devices in the EU and UK
Medical devices that conform to regulations require a conformity marking. Exceptional use medical devices are those that do not comply with regulations of a particular country and do not require a conformity mark. These medical devices may not conform to applicable regulations, but they could still potentially protect patient health.
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
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).
Global Labelling Requirements
How can we assure that we receive truthful information about a product from the manufacturer? Are Manufacturers/Distributors always honest with their claims? Find out from this article.
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.
With the UKCA deadline fast approaching, know what are the key highlight changes that MHRA is bringing into with the public opinion
With the UKCA deadline fast approaching and updating the existing regulation UK MDR 2002, MHRA has conducted a public opinion forum, Some of the key highlights are stated below, for your quick review. Transition Timeline The significant update on this forum discussion...
Global ISO Requirements
Ever wondered in this world of difference, is there any common thread amongst different countries? The answer is International Organization for Standardization (ISO). To know more, check out the following article.
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 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
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’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 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
‘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
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.
Definition of a Medical Device around the global market
The definition of medical devices is a vital factor in almost all regulations worldwide. This is because manufacturers need to know whether their product is a medical device before performing product risk classification and documentation.
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
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
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
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 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
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
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
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
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...
Summary of Safety and Clinical Performance (SSCP)
Summary of Safety and Clinical Performance (SSCP) acts as a vital document that allows the public to access information quickly. The information in the SSCP can be sourced entirely from the technical file. The technical file consists of the Post Market Surveillance...
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
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)
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...
ISO 20417:2021 – Information to be supplied by the Manufacturer
Engineered medical devices are introduced to the market for use in clinical scenarios. From a user’s perspective, the safe and effective usage of a medical device is highly influenced by providing appropriate accompanying information with the device labels and user...
Classification of Medical Devices Based on UK MDR 2002
The classification of medical devices in the UK market will be based on UK MDR 2002 from 1st January 2021. Medical devices are classified into a particular class based on the level of risk they pose to the patient and according to the intended purpose of use. The...
In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746
The In-vitro diagnostic medical devices Regulation (EU) 2017/746 (IVDR) brings EU legislation into line with technical advances, changes in medical science, and progress in law-making. The new Regulation creates a robust, transparent, and sustainable regulatory...