Monthly Archives: October 2022

Upcoming Webinar on EU MDR and IVDR Implementation

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Save the date for Friday 18 November from 15:30 to 17:00 CET for a unique webinar about implementation of the EU MDR and IVDR in various European member states and recognition of CE marked devices on the UK market, hosted by the Alliance of European Law Firms in which medical devices legal specialists from Spain, Italy, the UK, Germany, Greece, Belgium and the Netherlands will address:

  • A compare and contrast of how competent authorities in the respective countries deal with the concepts of placing on the market and making available under the MDR and IVDR, both crucial concepts for upcoming regulatory deadlines (and maybe some news on where we expect things to go with the MDR and IVDR);
  • A compare and contrast of national implementing measures for the MDR and IVDR, such as regarding sanctions for non-compliance, enforcement policy and specific subjects where the MDR and IVDR allow significant local discretion (e.g. reprocessing of single use devices and as regards in-house produced devices);
  • A compare and contrast of national exemption possibilities under articles 59 and 97 in view of expiring MDD/AIMDD/IVDD certificates and not timely obtain an MDR / IVDR certificate. 

Do not miss out on this unique opportunity to have all your questions about medical devices and IVD regulation implementation in the UK and important EU member states addressed by our expert panel:

  • Francisco Aranega from AMyS Law (Barcelona, Spain)
  • Laure le Calve from LCH Avocats (Paris, France)
  • An Vijverman from Dewallens & Partners (Leuven/Brussels, Belgium)
  • Ioanna Michalopoulou from Michalopoulou & Associates (Athens, Greece)
  • Mathias Klümper and Claudia Lützeler from Lützeler Klümper (Hamburg/Düsseldorf, Germany)
  • Paola Sangiovanni and Flavio Monfrini from Gitti and Partners (Milan, Italy)
  • Alex Denoon and Xisca Borras from Bristows (London, UK)
  • Erik Vollebregt from Axon Lawyers (Amsterdam, The Netherlands)

If you would like to attend, please send us an email to elisabetta.trecani@grplex.com and we will provide you with a link and technical information on joining the seminar well in advance.

Please feel free to share this save the date with colleagues or other people that may find the seminar interesting. If they send us an email, we can send them their own link and information for joining the webinar.

Abuse of Economic Dependence: Digital Platforms with a Key Role

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Italian law now includes a new provision on abuse of economic dependence with a special focus on digital space. Abuse of economic dependence is prohibited and triggers nullity of the agreement concerned and, if the abuse is considered to be affecting competition on the market, additional administrative sanctions issued by the Italian antitrust authority.

The Italian annual bill on competition modified Article 9 of Italian law no. 192/1998 and introduced a presumption of economic dependence applicable to contractual relationships where digital platforms play a “key role” in reaching end users and/or suppliers. The presumption shifts to digital platform operators the burden of proving the absence of economic dependence.

The law does not offer a specific definition of “digital platform”, therefore a wide range of entities, including marketplaces and search engines, can be included in the scope of the rule. For the provision to apply, however, a “key role” of the digital platform in reaching end users or suppliers must be proven. “Key role” is a concept that lends itself to multiple interpretations, but some commentators suggested that said criterion could be referring to the gatekeepers as defined by the Digital Markets Act (Regulation (EU) 2022/1925), even if it does not seem to exclude other “minor” operators.

The newly introduced provisions are expected to have a huge impact on relationships between digital platforms operators and their business partners.

Patients Associations Will Have a Stronger Voice

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Earlier this month the Italian Ministry of Health has issued guidelines that will allow patients to have a stronger voice at many levels of healthcare decisions. 

Patients associations will be involved in consulting, setting the agenda of the Ministry, co-planning, supporting implementation, generating evidence, as well as providing patients’ experience in the monitoring, evaluation and re-examination of measures.

Patients associations have welcomed the possibility to have a more formal and active role in the decisional processes that have an impact on healthcare: this may be a first step towards an a-political public participation in healthcare decisions.