A few years ago, many were shocked by the news that thousands of women across the world suffered harm caused by wrongly manufactured breast implants. For several years a French manufacturer had used industrial silicone instead of medical grade silicone to produce breast implants, in violation of the approval that had been issued by the notified body. Furthermore, a BBC investigation revealed that hundreds of thousands of individuals across the world could have been exposed to dangerously high levels of toxic metals from failing hip implants.
These revelations were some of the reasons why the European Commission issued, on 26 September 2012, two new regulation proposals to replace the three existing medical devices directives. One of the proposed regulations concerned in vitro diagnostic medical devices only, while the other one related to all other sorts of medical devices. These proposals marked the beginning of a long legislative process that led to the renewal of the regulatory framework on medical devices.
On 5 April 2017, the regulation on medical devices (hereinafter “MDR”) and the regulation on in vitro diagnostic medical devices (hereinafter “IVDR”) were adopted. They were published on 5 May 2017 and entered into force on 25 May 2017. The MDR will apply from 26 May 2020 and the IVDR from 26 May 2022.
Un nouveau règlement européen relatif aux procédures d’insolvabilité est entré en vigueur le 26 juin 2015. Il remplacera le règlement n° 1346/2000 à partir du 26 juin 2017.
Le 30 juin 2017, la nouvelle loi du 17 juin 2016 relative aux marchés publics, parue au Moniteur belge du 14 juillet 2016, entrera en vigueur pour les secteurs classiques (arrêté royal du 18 avril 2017, publié au Moniteur belge du 9 mai 2017).
Éclairage sur certaines nouveautés introduites par la nouvelle réglementation.
It is often said that RegTech is the new FinTech. That does not seem entirely correct.
While FinTech companies are offering financial services to customers (often in competition with traditional financial service providers), RegTech companies are more to be seen as technical support service providers. They are at the service of both disrupting and traditional financial institutions. RegTech, such as FinTech, InsurTech, and many others, is however also an example of an industry that is being rapidly altered by the use of technology. The industry, in this case, is not so much regulation itself, but rather the need to comply with the ever-growing regulation (mainly) in the financial sector.
ARRÊT DE LA COUR DE CASSATION DU 13 JANVIER 2017 (n° 15.0226.N)
L’annulation d’un contrat, puisqu’elle est rétroactive, implique que les parties soient autant que faire se peut replacées dans la même situation que si le contrat n’avait pas été conclu. Le principe peut sembler simple : chacun rend à l’autre ce qu’il avait obtenu sur le fondement du contrat.
Les effets de la nullité sont néanmoins particulièrement malaisés à mettre en œuvre lorsque celle-ci frappe des contrats relatifs à des biens dont la valeur fluctue dans le temps, tels que des actions.
La problématique a récemment donné lieu à un arrêt de la Cour de cassation du 13 janvier 2017.
Much has already been said and written about important new features of the PSD2 such as the introduction of new payment services, increased security measures, negative scope precision, incident reporting, improved home-host cooperation for agents / branches, etc.
For existing payment service institutions (“PSI”) (i.e. payment institutions which obtained their license prior to 13 January 2018 under the PSD1 regime) it is important to bear in mind that the license obtained under the former regime, will be put under review by the competent supervisor (i.e. the National Bank of Belgium or “NBB”).
The existing authorisation requirements under the PSD1 regime (programme of operations, business plan, safeguarding of funds, etc.) is completed under the PSD2 with additional requirements that are not only imposed on new applicants but also on already licensed PSI’s.
Simont Braun, which is the exclusive Belgian member of The Interlex Group, is proud to see this worldwide association of leading law firms ranked as “Elite” network by Chambers & Partners for the third year in a row.
The 2017 summary highlights Interlex’s “highly respected members” and praises that the association abides “by a strict acceptance and quality review policy, placing a strong focus on the personal relationships between member firms”.
Interlex has been ranked in the Elite category since Chambers & Partners began ranking networks.
Simont Braun is the exclusive member of The Interlex Group in Belgium. This association gathers leading law firms from all over the world that cooperate on a non-exclusive basis to provide a complete range of international legal services to their clients.
To rediscover Simont Braun’s rankings in Chambers 2017, click here.
Simont Braun is delighted to announce that Philippe Campolini has been promoted to partner, effective may 1, 2017.
Philippe started his career 10 years ago with Simont Braun's Intellectual Property department and has become an expert in patent law and copyright. “He has always been a key asset to our IP department, contributing to the high level of quality and professionalism, which characterizes the firm, as well as bringing contagious energy to the team,” says Fernand de Visscher, head of Simont Braun’s Intellectual Property practice.
Philippe Campolini advises major national and multinational companies active in various sectors, in particular the medical devices, life sciences, automotive, and IT sectors.
Philippe is appreciated for his tough analytical skills and perseverance in defending clients’ interests both in and out of court. He has significant experience in drafting cast-iron licensing, technology transfer and R&D cooperation agreements. Our clients can also count on Philippe’s in-depth knowledge of trade practices and unfair competition law, especially advertising and trade secrets law.
“With his sharp mind and pragmatism, Philippe is an excellent addition to our partnership,” says Managing Partner Vanessa Marquette. “Fluent in French, English, Dutch, German, Italian and Spanish, he will strengthen both the national and international development of our patent law and copyright practices.”
Par son arrêt n° 47/2017 du 27 avril 2017, la Cour constitutionnelle a répondu à deux questions préjudicielles relatives au sort des créances de l’Administration fiscale nées après l’ouverture d’une procédure de réorganisation judiciaire, lorsque celle-ci débouche finalement sur une faillite ou une liquidation du débiteur. Cette décision offre l’occasion de faire le point sur cette question.