As the COVID-19 pandemic continues to unfold, companies are finding it difficult to make informed decisions about their products, supply chains and regulatory obligations in the midst of uncertainty.
While it’s difficult to say for certain what the outcome of the current crises will be, we have compiled the latest information on the regulatory impacts of COVID-19 based on announcements from governing bodies and conversations with key decision-makers and regulatory experts.
Overall, the implementation of several new regulations may be postponed to allow both companies and regulatory agencies time to react to the crisis. However, there is no evidence this will alter reporting deadlines for established legislation.
In fact, reactions to the 2008 financial crisis suggest regulatory enforcement and market pressure for ethical and sustainable products could ultimately become stronger in the wake of the COVID-19 crisis.
At present, this is what we know about specific regulatory impacts:
The EU Waste Framework Directive & the SCIP Database
There has been some talk about delaying the January 5, 2021, go-live date for the Substances of Concern In articles as such or in complex objects (Products) (SCIP) database, however, no changes have been confirmed. A meeting will be held in June 2020 to further discuss the deadline, but historically, implementation dates have not been delayed.
During this time, some required data fields have changed (e.g. candidate list version is no longer required) and new ones may be added.
Brexit
Due to COVID-19 concerns, ongoing negotiations between the UK and the European Commission have been delayed. Changes are not currently anticipated for the December 31, 2020, full-exit date. However, negotiation delays could increase the likelihood of a hard Brexit, meaning there may be no trade deal in place at the time of the full exit.
The EU Medical Device Regulation
On April 3, 2020, the European Commission adopted a proposal to postpone the implementation of the Medical Device Regulation (MDR) for a period of 12 months in order to prioritize the health sector’s fight against COVID-19. While this must still be approved by the European Parliament, a quick approval process is expected once they are able to reconvene.
Once it passes, functionality of the European Database on Medical Devices (EUDAMED) will instead be announced by March 25, 2021, with reporting requirements beginning May 26, 2021.
While reporting requirements have been delayed until May 2021, companies should aim to have their supply chain data compiled and ready for submission by March of next year to give themselves adequate time and ensure they can make this deadline.
In the following weeks, continue checking back with the Assent blog for the latest news on the impacts of COVID-19 on the regulatory landscape and your supply chain. In the meantime, Assent can help you more efficiently collect and manage the supply chain data you need to meet regulatory requirements, enabling you to meet deadlines despite the challenges companies are currently facing around the globe. For more information about how Assent can help, contact us today.
