Regulating Medical Devices in the European Union

This chapter addresses the regulation of medical devices in the European Union. The overall goals of the European regulatory framework for medical devices are the same as the goals of the framework for medicines. It aims to protect public health by ensuring that medical devices are of good quality and safe for their intended use. However, the regulation of medical devices in Europe is very different from the regulation of medicines in two regards. First, unlike medicines, there is no pre-market authorisation by a regulatory authority for medical devices to lawfully enter the EU market. Second, unlike in the United States where the Food and Drug Administration is the primary regulator of devices throughout the nation, the European Union does not have a single regulator of medical devices. Instead, several organisations may be involved, and mainly a notified body in specific cases. The chapter then explains what constitutes a medical device in the EU and how devices are classified according to their level of risk in the EU. It then discusses how medical devices reach the market, how their risks are managed all along their lifecycle, and what kinds of incentives are provided for innovation and competition. The chapter also analyses the balance between public and private actors in the regulation of medical devices. It then concludes with case studies of innovative medical technologies that have challenged the traditional European regulatory scheme and that have led to many revisions in the 2017 device regulations.

Selected Aspects of Control-Command and Signalling On-Board Subsystem Verification

This article describes the procedures, standard parameters and control requirements to be performed in order to achieve EC verification of a Control-Command and Signalling On-board Subsystem. An analysis of issues related to the assessment of the on-board subsystem is presented in terms of the necessary checks that must be performed by a notified body and the issues of interoperability tests of the on-board ERTMS with track-side infrastructure. Providing railway interoperability is strictly related to the introduction of unified rules for the assessment and verification of the ETCS and GSM-R subsystems that are part of the European Rail Traffic Management System (ERTMS). The article describes procedures, standard parameters, requirements and necessary controls that must be implemented to carry out EC Verification of a Control-Command and Signalling On-board Subsystem. Reference is also made to the issues of ERTMS on-board compatibility tests with track-side infrastructure. Keywords: TSI, CCO, ERTMS, conformity assessment, interoperability

A futuristic study on in-vitro medical devices regulations

The In-Vitro Medical Devices Directive (IVDD) established in 1998 by the European Union met the requirements of the single medical device market. In the due course, IVDD could not regulate all new technical and medical developments in the sector. The IVDD 98/79/EC, was preceded with IVDR 2017//746; which defined and demonstrated conformity to essential requirements, established harmonized standards and facilitated the organization of ‘Notified Body’ (NB), Competent Authority oversight and market surveillance. IVDR implemented streamlines as defined in Annex I of the EU IVDR 2017/746 conforming to the relationships between the performance requirements and general safety, and Annex I of the EU Directive 98/79/EC for IVDD for the essential requirements. The importance of the Unique Device Identification and its implementation in the safety and conformity of the device was made stringent for the manufacturers. The recent developments in IVDR, with reference to EUDAMED database, enable the applicant for accessing of data entered for the revival, correction and the assessing of information.

Analysis and Laboratory Testing of Technical Injury Prevention Measures for Portable Combustion Chainsaws

Portable chainsaws for cutting wood, like other handheld machines, are commonly used for mechanical work. Portable combustion chainsaws are still used in many countries, including Poland, as basic wood harvesting machines and in agriculture. The use of portable chainsaws, however, poses a high risk of injury, especially with the phenomenon of kickback. Important European documents (e.g., 2006/42/EC) qualify these machines as a specific group, and assessing them for compliance with the essential applicable requirements (before placing them on the market) can be done with the participation of a third party (notified body). In Poland, only employees with appropriate training are allowed to work with chainsaws for professional wood harvesting. This paper presents the results of an analysis of the hazards posed by portable combustion chainsaws. A practical assessment was conducted of the effectiveness of the most relevant technical solutions used to protect operators from injury. Reference is made to tests on chainsaws that were carried out as part of scientific research (described in previous publications) and as part of research commissioned by market surveillance authorities operating in Poland. The presented research results show that the risk of injury caused by the use of chainsaws is influenced not only by the design features of the machines but also by their proper use, including the selection of equipment appropriate to the working conditions (e.g., wood type and properties, use of chainsaws for professional or non-professional work).

Ochrona interesów jednostki notyfikowanej w systemie oceny zgodności z zasadniczymi wymaganiami w prawodawstwie polskim i unijnym – wybrane zagadnienia administracyjnoprawne

The category of a notified body is inherently connected with the system of product conformity assessment. Evaluation of a product compliance with essential requirements constituting the European quality assurance mechanism for non-food products placed on the EU single market for goods is aimed at consumers’ health and safety protection. Moreover, it is to ensure a free movement of products. Notified bodies conduct conformity certification against the relevant requirements of the applicable technical harmonisation directive, hence their crucial role in the conformity assessment system. Notified body accreditation requires organisations to obtain a relevant administrative decision, under consideration of the requirements of Community law. The article presents the authorisation process for the provision of conformity assessment services, as well as the legal instruments which safeguard the rights of bodies applying for the appointment.

Compact Recreational Rebreather With Innovative Gas Sensing Concept and Low Work of Breathing Design

Recreational rebreathers are increasingly popular, and recreational diver training organizations now routinely offer training for rebreather diving. Few rebreathers on the market, however, fulfill the criteria of a dedicated recreational rebreather. These remain based on traditional sensor technology, which may be linked to rebreather use having an estimated 10 times the risk of mortality while diving compared with open circuit breathing systems. In the present work, a new recreational rebreather based on two innovative approaches is described. Firstly, the rebreather uses a novel sensor system including voltammetric and spectroscopic validation of galvanic pO2 sensor cells, a redundant optical pO2 sensor, and a two-wavelength infrared pCO2 sensor. Secondly, a new breathing loop design is introduced, which reduces failure points, improves work of breathing, and can be mass fabricated at a comparatively low cost. Two prototypes were assembled and tested in the laboratory at a notified body for personal protective equipment before both pool and sea water diving trials. Work of breathing was well below the maximum allowed by the European Normative. These trials also demonstrated that optical pO2 sensors can be successfully employed in rebreathers. The pCO2 sensor detected pCO2 from 0.0004 to 0.0024 bar. These new approaches, which include a new concept for simplified mechanical design as well as improved electronic control, may prove useful in future recreational diving apparatus.