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
The Italian administrative tribunal of Lazio region (tribunale amministrativo regionale del Lazio, “TAR”), the sole responsible court for the appeal of the Italian Competition Authority (“ICA”) decisions, has recently provided detailed clarification regarding when information exchange between competitors is not illegal. In a series of judgments regarding the TV post-production services case, the TAR overturned
Back in October 2015, as part of its Single Market Strategy, the European Commission declared that it would develop an agenda to encourage consumers, businesses and public authorities to engage confidently in the sharing economy (also known as the “collaborative economy”), where private individuals provide on-demand services to other people, without intermediaries. This peer-to-peer model
Belgian endives are a divisive vegetable: their bitterness delights some but repulses others. And even amongst Belgian endive enthusiast you’ll find some that prefer them raw – to maintain their crispness – while others like them cooked so that their bitterness comes out even more. But Belgian endives are no longer the exclusive battleground of
On 8 April 2015, the European Commission adopted Directive (EU) 2015/565 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells (“Directive 2015/565”) and Directive (EU) 2015/566 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells (“Directive
The enforcement of antitrust rules in the agricultural sector has been a taboo in Brussels for decades – and for good reason. Spending on the so-called Common Agricultural Policy (CAP) represented the vast majority of the EU budget until the beginning of the 21st century and the agricultural sector could consequently hardly be seen as open to the principles of the market economy. But things have slowly started to change with the creation of the World Trade Organisation and the reduction of farm subsidies in recent years.
On 26 February 2015, the European Commission published a progress report concerning the Commission’s five year Action Plan on Antimicrobial Resistance (“Action Plan”). The purpose of the progress report is to inform the European Parliament, the EU Member States and other stakeholders about progress to date in relation to the implementation of the Action Plan.
On 5 September 2014, the European Commission released the Implementation report on the Commission Communication on Rare Diseases: Europe’s challenges (COM(2008) 679 final) and Council Recommendation of 8 June 2009 on an action in the field of rare diseases (2009/C 151/02) (the “Implementation Report”).
As part of the European Commission’s drive to take action concerning rare diseases, the Implementation Report analyses the extent to which the Commission’s measures on rare diseases have been established.
The Implementation Report provides an overview of the European Union (“EU”) rare diseases strategy to date, including the Commission Communication (COM(2008) 679 final) and Council Recommendation (2009/C 151/02).