1. Introduction Shortly after updating the related draft Questions and Answers document (see our blog), the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form.
1. Introduction The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing clinical trials within the Regulation. The draft document has been submitted for discussion to the Expert Group on Clinical Trials.
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’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
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
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
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
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).
Following the European Commission’s prohibition of the Alstom-Siemens transaction, the French and German governments published a manifesto calling for a reform of current EU merger rules, in order to shape a “European industrial policy fit for the 21st Century”. This manifesto appears to be directly addressed to the next European Commission, which will be renewed following the European elections this year.
Introduction The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities responsible for the procurement of (in vitro) medical devices with guidance concerning Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR). This
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries. This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the implications of the Medical Device Regulation (MDR) and the In Vitro Medical Device Regulation (IVDR). The factsheet is intended
Introduction On 19 December 2018, the European Commission published a Communication addressed at the EU institutions. The Communication relates to the preparation for the withdrawal of the United Kingdom from the European Union, in case of a “no-deal” Brexit. The Communication discussed 14 measures that the European Commission has adopted to prepare for the “no-deal”
Price algorithms are clearly the “talk of the town” in the European competition law community these days. Just last week, the German Monopolies Commission published a report in which it discusses potential anti-competitive effects of price algorithms and proposes far-reaching amendments to the competition law enforcement framework. Meanwhile, the European Commission has announced a consultation
The European Commission has adopted a “New Deal for Consumers” package which aims to empower consumers, promote fairness and build trust across the single market. The package was adopted by the Commission in response to an evaluation on EU consumer protection and marketing directives. The evaluation found such laws need to be better applied, enforced
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
After three years of negotiations, the European Union is nearing the end of a long process to simplify and harmonise the rules for organic food production and the labelling of organic products. Council Regulation (EC) 834/3007 currently defines the minimum standards for organic products that are produced, manufactured, imported into, sold or traded within the
On 6 October, the German Federal Cartel Office (“FCO”) launched its new series of papers on “Competition and Consumer Protection in the Digital Economy”. The first paper deals with “Big Data and Competition”. The same day, a “real-life example” of competition enforcement in Big Data became public. The EU Commission confirmed unannounced inspections in “a few
The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which expands the scope of the current confidentiality arrangements that apply to the cooperative law enforcement activities conducted by the regulators. The new confidentiality commitment allows the regulators to share
The European Commission has published a guidance concerning “Safety Features for medicinal products for human use” (Guidance). The Guidance is in the form of a “Questions and Answers” document. It is intended to facilitate the implementation of the EU Falsified Medicines legislation.
The European Commission has opened an online stakeholders’ consultation for the evaluation of the European (“EU”) legislation regarding blood and, tissues and cells. The online consultation has the form of a questionnaire, and it was initially open until the end of August 2017. Upon the request of various stakeholders, the European Commission has recently decided to keep
Will Germany establish a “Digital Agency” to monitor compliance with competition law rules in digital markets? Will a German “Digital Antitrust Enforcer” become a role model for a European protectionist approach against American and Asian platform providers?
The German Federal Ministry for Economic Affairs and Energy seems to see a pressing need for regulation in digital markets. The White Paper “Digital Platforms”, published on the 20 March 2017, provides an outlook on possible forms of digital regulatory policy in Germany and potentially also in Europe. Of particular interest from a competition law perspective is the proposal to establish a new “Digital Agency”.
In September 2016, the European Commission granted a 30% fine discount to Altstoff Recycling Austria for cooperating with an investigation into its alleged abuse of a dominant position in the Austria waste management market (see our previous post here). The discount was granted on the basis of Paragraph 37 of the 2006 Fining guidelines, which allows
The current eighth European Union Research, Technological Development and Demonstration (“RTD”) Framework Programme, entitled Horizon 2020, will expire on 31 December 2020. On 12 October 2016, the Director General for Research and Innovation announced that the European Commission is currently starting to work on and plan for the ninth RTD Framework Programme (“FP9”) which will
The stage is set for the Euro-drama of our time. We know that giving effect to the UK’s vote for Brexit could require as many as four sets of distinct but closely linked negotiations, or “acts”, dealing with the terms of: the UK’s withdrawal from the EU; the UK’s future relationship with the EU after