On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more
10/10/2019
/ Cybersecurity ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
International Medical Device Regulators Forum (IMDRF) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Network Security ,
Pharmaceutical Industry ,
Popular ,
Regulatory Oversight ,
Vulnerability Assessments
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...more
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)...more
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....more
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...more
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...more
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”)....more
2/14/2019
/ Biotechnology ,
Commercial Marketing ,
EU ,
European Commission ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Regulatory Oversight ,
UK ,
UK Brexit
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”)....more
2/7/2019
/ EU ,
Foreign Manufacturers ,
Healthcare ,
Imports ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Sales & Distribution Agreements ,
Supply Chain ,
UK ,
UK Brexit
Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more
12/7/2018
/ Biotechnology ,
Data Privacy ,
Digital Health ,
Drug Pricing ,
Emerging Markets ,
General Data Protection Regulation (GDPR) ,
Investment ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Regulatory Standards ,
Sunshine Laws ,
UK Brexit
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...more
The new Belgian Royal Act of 9 January 2018 on Biobanks will apply on 1 November 2018. The Royal Act implements Article 22 of the Belgian Law of 19 December 2008 on the procurement and use of human body material for human...more
The European Commission just published an “implementing measures rolling plan” in relation to the MDR and IVDR which are scheduled to apply from 26 May 2020 and 26 May 2022 respectively....more
On 9 August 2018, 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...more
In the recently published White Paper governing the future relationship between the United Kingdom and the European Union, the UK proposes a "common rulebook" between the parties in relation to goods....more
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...more
On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health....more
5/8/2018
/ Belgium ,
Data Protection ,
Disclosure Requirements ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
Medical Devices ,
Personal Data ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Standards ,
Sunshine Act
The European Commission’s Implementing Regulation concerning the list of codes defining the scope of designation of notified bodies under the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”) has...more
The Competent Authorities for Medical Devices (“CAMD”) has published a roadmap concerning the implementation of the Medical Devices Regulation (“MDR”) and In Vitro Diagnostic Regulation (“IVDR”). The roadmap has been prepared...more
The simple fact is that the Chinese antitrust regulators are determined to up their enforcement activities in the life sciences industry. Almost immediately after drug pricing was liberalised in 2015, an antitrust enforcement...more
In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last week, the European Commission issued a...more
On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”)....more
On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more