EU Approves 1 Year MDR Delay
On April 3, 2020, the European Commission proposed a one year delay of the Medical Device Regulation (MDR). The original Date of Application was set for May 26, 2020.
The COVID-19 challenge
The chief reason for the delay is the COVID-19 pandemic. The virus has affected the medical device industry in several ways.
First, the virus has created sudden shortages of certain devices and products. The Commission believes it’s important to make more devices available rather than creating potential shortages through transitioning to the MDR.
Notified Bodies shortfall
Even before the pandemic, there was a lack of certified Notified Bodies. Manufacturers depend on Notified Bodies to pass a product through a certificate procedure. According to MDR, all existing Notified Bodies had to run through another recertification by the due date of May 26.
The situation was further complicated by the need for a recertification of a significant number of class Ir (class 1) products. It became unforeseeable whether there was a necessary amount of Notified Bodies and how many of these would preserve an admission for class Ir certification.
Due to COVID-19, the Notified Bodies that exist cannot carry out on-site audits. Like so many other organisations, many of their staff are working from home or are ill.
The New Regulation delays the application date of the MDR by one year – from 26 May 2020 to 26 May 2021. Unusually for the European Parliament and Council, this came into effect on the very day of its publication – 25 April 2020. EU regulations typically come in to effect the day after publication so this reflected the need for urgency in light of the pressure on the medical device industry due to COVID-19.
To quote from the Official Journal of the European Union:
“…Given the unprecedented magnitude of the current challenges and taking into account the complexity of [the MDR], it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that regulation from 26 May 2020 as laid down therein.”
The full story
The MDR follows in the footsteps of the Unique Device Identification initiative implemented by the American FDA and effective since 2014.
Both MDR and UDI require uniform guidelines for the consistent labelling of medical devices to allow an increase in patient safety and transparency in the supply chain. A thorough analysis of these guidelines and requirements can be found in a Medical Industry UDI White Paper created by our product partners and available on the FOBA website.
As FOBA’s White Paper mentions, one of the major challenges for manufacturers is the implementation of the appropriate direct marking technology.
Laser marking is ideally suited for the direct marking of medical devices. It meets all criteria relevant for safe product marking based on medical standards and UDI and MDR requirements.
MDR has been delayed but it has not gone away. To meet MDR requirements and find a laser marking system that meets your specific production needs, please contact firstname.lastname@example.org