In the light of new research, Peter Muller and Mike Baird of Schlafender Hase assess how well Class 2 and 3 device manufacturers in Europe and the US are adapting to a rise in regulatory controls.
Q2/24 Life Science and Health Care Law Updates by Hogan Lovells including key trends in the EU and Big Five (France, Germany, Italy, Spain, UK) regulatory, corporate, compliance, competition, and privacy.
Law firm, Hogan Lovells, analyzes the changes to the updated enforcement policy and provide key takeaways for entities responsible for communication regarding approved/cleared medical products.
Law firm, Hogan Lovells, analyses the implications of the AI Act for the Medtech sector and highlight a number of key challenges for medical device manufacturers and their partners in aligning conformity routes for their products under the AI Act.
Cevian Capital increased its position in Smith & Nephew to a 5% stake in the British medical equipment maker, making it Smith & Nephew’s second largest shareholder according to reports by Reuters.
As technology component pricing continues to rise, MedTech manufacturers are applying proven methods and exploring new approaches to maintain profitability and extend product lifecycles.
Medical technology companies are caught between rising costs and increasing inflation as well as stricter regulations due to the introduction of the EU Medical Device Regulation. A strategic price adjustment can help to face these challenges and secure the companies’ success in the long term.
Selecting a strong medical device contract manufacturer is critical to ensure supply chain resiliency, regulatory compliance, and long-term success for a medical device OEM. This article is a guide to the most important questions to ask yourself and your contract manufacturer to help ensure a successful partnership.
The doctrine of assignor estoppel is intended to prevent an inventor who has sold or “assigned” a patent from then challenging the patent’s validity. Mauricio Uribe, a patent lawyer with Knobbe Martens, discusses what medical device inventors and acquiring companies should do to ensure they comply with the Supreme Court and Federal Circuit’s clarification of assignor estoppel.
Digital transformation requires a clear vision, buy-in at every level, and significant investment. Here are three steps to streamline the process.