Whitepaper su regolamenti e sviluppi settore dispositivi medici

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Developing and maintaining a quality management system for IVDs

There are many different requirements with which in vitro diagnostic manufacturers have to comply in order to place products on the market. At the core of most of these requirements is a fundamental need to have a good quality management system (QMS) in place. There are several regulations and standards that focus on QMS requirements, but this paper primarily examines the QMS requirements in the new In Vitro Diagnostic Device Regulation (IVDR) 2017/7462 which has entered into force as of 26 May 2017 and will serve as the basis for access to the European market. Complying with the requirements of BS EN ISO 13485:2016 will largely fulfil those requirements established in the IVDR.

Implementing the EU Medical Devices Regulations

The European Union (EU) Medical Devices Regulation (EU 2017/745) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU 2017/746) (IVDR), now apply. Important terms used in the regulations are ‘entry into force’ and ‘date of application’. The publication of the text in the Official Journal of the European Union was on 5 April 2017. The ‘entry into force’ was the date when each regulation came into effect, twenty days after publication. The ‘date of application’ reflects the date from which the requirements apply and the Active Implantable Medical Devices Directive (AIMDD - 90/385/EEC), Medical Devices Directive (MDD - 93/42/EEC) and In Vitro Diagnostic Medical Devices Directive (IVDD - 98/79/EC) were repealed.

EU MDR and IVDR: unique device identification

The convergence of the pharmaceutical and medical devices industries

Nanotechnology

Nanotechnology is now a mature subject in terms of the basic science, and while there were many claims for what it could achieve 20 years ago, the application to medicine and healthcare has now become more well defined. When considering nanotechnology's future in the medical devices field, it is best to divide the field into five main categories: medical image enhancement; drug delivery vehicles; nanomaterials for functional coatings; therapeutic aspects of nanomaterials that make use of their small size and properties; and finally biosensors that make use of nanoparticles. There are common themes that apply to each of these fields and in this review we will summarize these and identify gaps in understanding and opportunities.

Requirements and your responsibilities for medical device vigilance reporting

This paper outlines the requirements specific to incident reporting, vigilance, mandatory problem reporting, medical device reports and adverse event reporting, herein termed ‘vigilance’, in comparison with the requirements of the recently published European Medical Device Regulation (MDR) to support those working with these aspects within the MDSAP Programme. Manufacturers who wish to supply their devices outside of these regions may have many more requirements to meet, the discussion of which is beyond the scope of this paper.

The European Medical Devices Regulations

This paper addresses a number of areas, including: post-market surveillance (PMS) as an element of the management of clinical evidence throughout the device lifecycle; the PMS system, which is the comprehensive process used to collect, analyze and take action on PMS information; the PMS plan, which describes the application of the PMS system to a device or device family; preparation of a summary report of PMS information; complaint handling and reporting of vigilance; and, electronic submission of vigilance data and summary reports of PMS.

Cybersecurity of medical devices

This paper considers the cybersecurity challenges facing the healthcare sector arising from the convergence of technology, hyper-connectivity and recent developments in regulation. It explains the issues and tensions between safety and security and what can be done to resolve them. The paper highlights emerging good practice and approaches that manufacturers can take to improve medical device security throughout its lifecycle. The paper will also be of interest to others in the sector, including healthcare providers, IT suppliers, notified bodies and regulato

Medical Device services

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Whitepaper su regolamenti e sviluppi settore dispositivi medici

Medical Device services

Argomenti più richiesti

Training dedicato

Market access

Whitepaper su regolamenti e sviluppi settore dispositivi medici

A notified body’s perspective on the clinical evaluation requirements under the MDR

EU MDR and IVDR: unique device identification

Phthalates and endocrine disruptors

The convergence of the pharmaceutical and medical devices industries

Person responsible for regulatory compliance (PRRC) - MDR/IVDR Article 15

Software as a medical device - A comparison of the EU’s approach with the US’s approach

Medical device clinical investigations – What’s new under the MDR?

Machine learning AI in medical devices