EU MDD to MDR – A major change
Medical Device Directive (MDD) which is in action now and will shortly be superseded by Medical Device Regulations (MDR), had been practiced and implemented by the industry for over several decades.
The advent of new rules, European Medical Device Regulations (EU MDR), is a major change to be implemented across the medical device industry this year, and was created primarily to make the requirements more clear and explicit for easier compliance, and to encompass applicability for newer medical device technologies based on the marketing history and learnings that regulators have gathered over the past years. However, due to the outbreak of COVID-19, this seems to be getting delayed –
As stated by European Commissioner for Health and Food Safety, Ms. Stella Kyriakides the authorities shall consider to delay the implementation of MDR by one year.
A final decision is yet to be made but if approved, considering the current scenario, it will be a great relief to the medical device manufacturers. The trade association MedTech Europe called the European Commission on Monday (March 23, 2020) to pause the application for MDR and resume it after six months when the COVID-19 would pass.
EU MDR – Timeline
The proposed last date for the implementation of MDR was May 26, 2020, with a time period of about 4 years, and the last date of around May 2024 for a complete transition.
EU MDR last date – when would we know?
The Socialists and Democrats in the European parliament also proposed the postponement of MDR through a request letter on Tuesday, March 24, saying that very few resources are available to assist the implementation of MDR as of now.
European Commission spokesman Stefan De Keersmaecker informed that the MDR implementation proposal would be submitted to the Parliament and Council in early April and that they would ask them to decide the deadline as soon as possible.
Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.