MDR postponed with 1 year
Regulation (EU) 2020/561 has been drafted based on the proposal and it was published in the Official Journal of the European Union on the 24th of April 2020. Regulation (EU) 2020/561 states that the COVID-19 outbreak and associated public health crisis have a major effect on various areas covered by the MDR. They fear this might lead to improper implementation and application of the MDR by its primary date. To quote bullet point (5):
In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745. Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the additional resources required by Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of those provisions of Regulation (EU) 2017/745 by one year.
Conclusion is that medical device manufacturers have one more year to comply with new MDR requirements. To further assist manufacturers and other economic operators in preparation for MDR compliance, Unitron Regulatory updated and made available a costless download of a user-friendly MDR readable edition. This readable edition is featured with colored keywords and is indexed and internally hyperlinked, which makes it very easy to read and navigate. You can even print it as a booklet for use in your office.You can download the MDR readable edition here.