EU


Guidance on the vigilance system for CE-marked devices and the Device Specific Vigilance Guidance (DSVG) Template

This newsletter is aimed toward introducing the Device Specific Vigilance Guidance (DSVG), a pivotal document aimed at harmonsing vigilance reporting and offering comprehensive guidance for manufacturers of Specific Devices. This guidance is designed to provide clarity on vigilance reporting of Specific Devices to the relevant Competent Authority and should be considered alongside the requirements of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). It’s important to note that the DSVG neither replaces nor extends the existing regulatory requirements. Key Reporting Obligations Manufacturers......

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Role of the Person Responsible for Regulatory Requirements

What is this role? This is a new regulatory compliance role introduced by the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746. This is the first time a role of this type is officially recognised and must be appointed by the manufacturer. This is a separate role to that of the Authorised Representative. How to comply? Article 15 in the MDR and IVDR is entirely dedicated to the definition of the requirements, tasks and duties of the Person Responsible for Regulatory Compliance. It requires that manufacturers have at......

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Medical Device Regulation (MDR) European Union (EU) 2017/745 Transition - What is required by the May 2020 deadline?

When does the MDR become applicable? The MDR will come into force May 2020. What does the introduction of the MDR mean? The MDR replaces the EU’s existing Medical Device Directive (MDD) (93/42/EEC) and Directive on Active Implantable Medical Devices (90/385/EEC). The purpose of the MDR is to improve traceability and safety of devices in the EU. Changes required to transition to MDR: Assess Device Classifications Some device classifications as per the MDD have been retained, while more have become more stringent, which can result in a device being reclassified as a......

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Importance of Post Market Surveillance for medical Devices

Post market surveillance (PMS) activities are part of the manufacturer’s overall quality management system, whereby it provides continuous feedback about a device on the market, ensuring that a high standard of product quality is maintained, as it monitors the safety of the device post launch. PMS is a requirement for the main markets i.e. US, Europe, Australia, etc. In Australia, the Therapeutic Goods Administration (TGA) is responsible for medical devices, this includes the monitoring of the ongoing safety, performance and quality, of devices which have been included on the Australian Register of......

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Overview of the role of Key Stakeholders in the Medical Device Regulations

The new MDR will apply across EU Member States from May 2020, under this regulation there are defined obligations which lie with the major stakeholders in the device lifecycle. These obligations need to be fulfilled to ensure compliance with the regulation when placing the device on the market. Manufacturer Dependent on classification of the device, will get a CE certificate from the Notified Body or self-certify the device. Affix CE mark. Responsible for placing CE marked product on the market. Responsible for registering products on the EUDAMED database Retain technical documentation, CE......

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Post Brexit Market Access for Medical Devices

With a Brexit deal or no Brexit deal still on the cards, when either outcome comes into effect, the UK will be considered a third country. Countries which are located outside the EU are considered ‘third countries’. To ensure uninterrupted market access, it is advised for manufacturers to prepare for Brexit. Implications for product on the Australian market: The TGA will continue to recognise conformity assessments from UK based Notified Bodies for existing and new ARTG listings and applications. The TGA will recognise: Device certifications by UK notified bodies through 31 Dec......

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Unique device identifiers (UDI)

What is it? This is a system by which medical devices are identified through their distribution and use. UDI information must be placed on the label and/or package of the device and will be both human and machine-readable form. The UDI is a set of alphanumeric codes which consists of both a device identifier (this is company and product code) and production information (manufacturing information: product name, expiration date, lot/batch numbers, manufacturer details). How and when to comply: US (FDA)In 2013 the FDA released a rule which determined that there would be......

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Understanding MDSAP

MDSAP (medical device single audit program) is an international program, which allows a single regulatory audit of medical device manufacturer’s QMS’ for the following regulatory agencies: • Therapeutics goods Administration (TGA) – Australia • Agência Nacional de Vigilância Sanitária (Anvisa) – Brazil • Health Canada (HC) – Canada • Food and Drug Administration (FDA) – US • Ministry of Health and Labour and Welfare (MHLW) – Japan The benefit of MDSAP, is one single quality system inspection that will encompass 5 markets versus having to complete 5 separate audits. One single audit......

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The Importance of Risk Management

Risk management is a key component to demonstrate regulatory compliance for medical devices, it contributes to the medical device company’s ability to meet the regulatory requirements for approval from local regulatory authorities. Effective risk management is essential for determining whether the benefits of the product outweigh any potential risk to the patient. ISO 14971 ’Medical devices – Application of risk management to medical devices’ is the international standard for the application of risk management by a manufacturer to medical devices, including in vitro diagnostics (IVD’s). ISO 14971 is accepted by the TGA......

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Why is it so important to review and update your regulatory strategy?

Formulating a well defined and researched regulatory strategy is vital for medical device and in-vitro diagnostic (IVD) companies. The regulatory world is constantly evolving, with Brexit and the introduction of the new MDD and further changes planned for the coming years, it is important that a regulatory strategy is reviewed and updated as new and updated requirements are identified. New requirements and/or updates could have a significant impact on existing or new products. Regulatory standards are used to assess the safety, efficacy and quality of medical devices throughout the product lifecycle. There’s......

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