…transparency for NBs and providing guidance around MDR implementation. In an April 2023 statement, Team-NB estimated that the 38 designated NBs currently operating in Europe could issue 3,200 MDR certificates…
…transparency for NBs and providing guidance around MDR implementation. In an April 2023 statement, Team-NB estimated that the 38 designated NBs currently operating in Europe could issue 3,200 MDR certificates…
Input and support from experts within your target disease area are vital to the development and commercialization of new medical technologies. But it can be difficult, especially for new companies,…
Input and support from experts within your target disease area are vital to the development and commercialization of new medical technologies. But it can be difficult, especially for new companies,…
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs…
The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs…
…long run. References: [1] DIHK (2022). Gesundheitswirtschaft unter Druck. https://www.dihk.de/resource/blob/73350/4912206cdf7717fd3e770a3927f58537/gesundheitsreport-fruehsommer-2022-data.pdf [2] Obelis Group (2022): What are the effects of the implementation of MDR on the EU medical device market? https://www.obelis.net/news/what-are-the-effects-of-the-implementation-of-mdr-on-the-eu-medical-device-market/…
…long run. References: [1] DIHK (2022). Gesundheitswirtschaft unter Druck. https://www.dihk.de/resource/blob/73350/4912206cdf7717fd3e770a3927f58537/gesundheitsreport-fruehsommer-2022-data.pdf [2] Obelis Group (2022): What are the effects of the implementation of MDR on the EU medical device market? https://www.obelis.net/news/what-are-the-effects-of-the-implementation-of-mdr-on-the-eu-medical-device-market/…
…any need to immediately apply any necessary corrective or preventive actions”- EU MDR Art.2 (60), EU IVDR Art.2 (63) EU MDR and IVDR place special importance on collecting clinical and…
…any need to immediately apply any necessary corrective or preventive actions”- EU MDR Art.2 (60), EU IVDR Art.2 (63) EU MDR and IVDR place special importance on collecting clinical and…
…devices play a crucial role in healthcare, as they enhance accurate diagnoses and treatment decision for healthcare professionals. The European In Vitro Diagnostic Regulation ((EU) IVDR 2017/746) regulates the manufacture,…
…devices play a crucial role in healthcare, as they enhance accurate diagnoses and treatment decision for healthcare professionals. The European In Vitro Diagnostic Regulation ((EU) IVDR 2017/746) regulates the manufacture,…
An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European…
An extension to the EU MDR transition period, approved by the European Council on March 7, is now in force following its publication in the Official Journal of the European…
Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible….
Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible….
…12 to 18 months to get approval. EU MDR represents a completely different pathway to EU approval, and they keep extending the transition period, because no one right now has…
…12 to 18 months to get approval. EU MDR represents a completely different pathway to EU approval, and they keep extending the transition period, because no one right now has…
…safety controls. And specific guidance around e-labeling is being added at a quick pace. In December 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 for the use…
…safety controls. And specific guidance around e-labeling is being added at a quick pace. In December 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 for the use…
