The date of application of MDR of 26th May 2020 has long been recognised as a very ambitious target by many in the medical devices sector. The pressure among stakeholders whether they be economic operators, notified bodies or competent authorities to be ready in time has been intense. The delay of Eudamed and the well-documented issues around capacity in the Notified Body network are just two examples of areas of difficulty in being ready for MDR implementation. The outbreak of Covid-19 has added unprecedented extra pressures on the medical device sector. The European Commission is working on a proposal to postpone the application date of MDR by one year. It will be submitted to European Parliament and Council in early April for adoption before the end of May. We will keep you updated about MDR issues as the proposal to delay implementation progresses.We hope that you find this essential guide to be useful. wider series looking at issues relating to the introduction of MDR. Read the full article here. Read the full article here. MDR articles that look at the changes coming into play with the new medical device regulations. In this article, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read the full article here. Read the full article here. MDR, we look at Conformity Assessment routes in this article. We look at changes under MDR and the assessment routes for different device classifications. Read the full article here. Read the full article here. Read the full article here. Read the full article here.
Acorn Regulatory has been at the forefront of the MDR issue. While many economic operators across the industry have been busy preparing for implementation in May 2020, there is some uncertainty at present (March 2020) whether this date will be delayed because of the necessity of the life sciences sector to combat the Covid-19 crisis in Europe. The ‘Essential Guide’ looks at MDR from a range of perspectives. Our expert MDR team has also written several whitepapers on the issue and they can be accessed here.