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Tag Archives: Medical Devices

Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

1.            Introduction On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. This is part of MHRA’s continued effort to regulate medical devices in the event of a no-deal Brexit. With the possible withdrawal of the UK from

New MDCG Guidance on Summary of Safety and Clinical Performance under the Medical Devices Regulation (MDR)

1.            Introduction On 26 September 2019, the European Commission published a new Guidance of the Medical Device Coordination Group (MDCG) concerning the Summary of Safety and Clinical Performance (SSCP). This document is aimed at manufacturers and notified bodies and provides guidance on the presentation, content and validation of the SSCP under the Medical Devices Regulation

The European Commission has published Guidelines concerning the use of phthalates in medical devices

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of phthalates in medical devices. The Guidelines concern the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic and toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties. The

Publication of rules on designation of expert panels under the Medical Devices Regulations

1.            Introduction In the process of getting ready for the implementation of the forthcoming medical devices Regulations the European Commission published on 10 September 2019 the Commission Implementing Decision (EU) 2019/1396 (Decision) laying down rules on designation of expert panels in the field of medical devices. These expert panels are to be designated to provide

Medical Device Contractor Settles FCA Allegations Based on TAA Violations

On Thursday, August 8, 2019, the Department of Justice (“DoJ”) announced that Danish medical device company Ambu, Inc. (“Ambu”) will pay $3.3 million to settle False Claims Act (“FCA”) allegations that it violated the Trade Agreements Act (“TAA”) (19 U.S.C. § 2518) by selling products to the Defense Logistics Agency (“DLA”) and the Department of

European Commission draft implementing regulation on the reprocessing of single-use medical devices: public consultation is open

On 23 July 2019, the European Commission published the draft Commission Implementing Regulation (hereafter “Draft”) regarding Common Specifications for the reprocessing of single-use medical devices. The Draft is to implement the requirements of Article 17(3) of the Medical Devices Regulation 2017/943 (hereafter “MDR”). Article 17 MDR provides that under certain conditions, health institutions can reprocess

European commission publishes Additional Guidance regarding the Medical Devices Vigilance System

The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), provide for the requirement for a European Medical Devices Vigilance System. The Medical Devices Vigilance System is the European system for the notification and evaluation of incidents

The European Commission releases an updated Borderline Manual for medical devices

Introduction The European Commission has updated the Manual on borderline and classification in the community regulatory framework for medical devices (Borderline Manual). The Borderline Manual is intended to assist manufacturers in determining whether their product falls within the definition of a medical device laid down in the Council Directive 93/42/EEC concerning medical devices (MDD).

Poland: official position of the competent authority on consequences for medical devices in the event of a no-deal brexit

On 1 March 2019[1], the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices. It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”). This Notice applies, among others, to medical devices, active implantable medical devices and in vitro medical devices. The Q&A

The European Commission publishes nine new guidance documents in relation to the MDR and IVDR

On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic Medical Devices Regulation (“IVDR”). The MDR and IVDR will apply from May 2020 and May 2022 respectively. These documents include: Factsheet for

MDR and IVDR: the European Commission published some guidance documents

In the last couple of days, the European Commission published five new documents intended to provide guidance to manufacturers concerning the implementation of the EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The documents which are available on the European Commission website include the following practical guides: Factsheet for

MDR and IVDR: MedTech Europe calls for an extension of the transitional provisions

On 27 July 2018, the European trade association representing the medical technology industries, MedTech Europe, issued a position paper in which the association requests the European Commission, the European Parliament and all EU Member States to have an urgent discussion concerning the timelines for the application of the Medical Devices Regulation (MDR) and In Vitro

The European Commission Is Considering Opening an Antitrust Probe for Parallel Imports in the Pharmaceutical Sector

The European Commission is looking into several parallel imports cases, including in the life sciences industry, with a view to opening formal antitrust investigations, which may eventually lead to fines being imposed. The pharmaceutical sector is understood to be under scrutiny in at least one of the current informal investigations, according to a leak in

Digital Health: CE marking of medical devices

In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical device and lay down the technical and procedural obligations that must be followed by the manufacturer of a medical device prior to affixing a CE mark to the product.

The HPRA published a MDR/IVDR Guide for Distributors of Medical Devices

The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations that must be met by distributors in relation to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

Brexit – what’s next for medical devices?

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and

Draft Fee Regulations – Attempts to Address Incentivising Loopholes

Section 18A of the South African Medicines Act (the “Medicines Act“) prohibits the supply of any medicine, medical device or in-vitro diagnostic device, according to a bonus system, rebate system or any other incentive scheme. Although no definitions in respect of these prohibited activities have been included in the Medicines Act, considerable guidance as to

UK MHRA Issues New Guidance on Human Factors and Usability Engineering for Medical Devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing medical devices and ensuring that they meet the essential safety and performance requirements for devices. ‘Human factors’ refers to how a person uses or interacts with a device taking into account the context and

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro Diagnostic Medical Device Regulation (“IVDR”). The MDR and IVDR entered into force on 25 May 2017. Most of the requirements under the MDR