Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complemented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.
Less than 25% of medical device manufacturers are ready to meet EU MDR deadline
Less than a quarter of medical device companies plan to be fully compliant with the new European Union’s new Medical Device Regulation when it goes into effect on May 26, 2021. And even though the deadline was postponed for 1 year due to the global pandemic, the majority of medical device manufacturers are lacking behind the schedule.
According to this survey, a wide range of medical device manufacturers, mostly from the EU and North America, responded to the question of whether they were planning to become fully compliant with the new EU MDR. Only 27% expected to be fully compliant back in 2019.
Now, the number has been reduced to 18% of medical device companies who are expecting to become ready for full compliance before the deadline on May 26, 2021.
Nearly half of these companies, almost 46%, plan to leverage the transitional provisions included in the MDR legislation to continue selling in the EU through 2024 while continuing to work on their compliance programs – programs that are expected to cost more than US 5million to help companies achieve full compliance.
The deadline was extended due to COVID-19
Last year, only a month and a half before the deadline, the EU Commission published a statement, announcing that due to the coronavirus pandemic, it proposed to postpone the date of application of the EU MDR by one year to the present deadline of May 26, 2021. The extension was a response to the fact that the COVID-19 pandemic became the topic dominating the headlines in Spring 2020, but also due to the high burden on national health authorities, health care institutions, and economic operators.
The industry itself was also further challenged by the consequences of the pandemic, including lockdown, the increased demand for respiratory ventilators, and the current work becoming ready for EU MDR compliance.
This was certainly welcome news – not just for the manufacturing companies – but for everyone involved. We have previously reported on the lack of Notified Bodies able to conduct on-site audits and forced to work from home. The postponement certainly came at the right time, offering relief for both legislators, auditors, and the industry itself.
Only a pleasure deferred
But, was the 1-year extension a god-sent opportunity, allowing medical device companies the ability and time to get their houses in order?
Well, companies who would have to undergo a conformity assessment according to MDR in the period from May 26, 2020, to May 26, 2021, but are not ready for it yet, can take a deep breath. However, not all transition periods and expiry dates will be postponed by 1 year but will remain with the known dates. In the worst case, this means that even more manufacturers will have to obtain certification in even less time.
What should manufacturers do now?
Indeed, there are some aspects that manufacturers absolutely must handle by now. These include amongst others:
- Training and appointment of the “person responsible for regulatory compliance”
- Setting up or completing the QM system (certification according to EN ISO 13485:2016 would be ideal) The extent of the QM system depends on the risk class of the devices, the size of the company, and other factors.
- The structure and contents of the technical documentation must be adapted according to the changes in the MDR
- Clinical evaluation of all medical devices must be updated and, if necessary, clinical investigations must be conducted
In addition to the tasks mentioned above, it is important that you develop a plan for your company for the time of the transition to MDR, defining the product life cycle of your medical devices.
Also remember, even if devices have previously been approved under the MDD, they must go through the entire conformity assessment process of the MDR and comply with the respective requirements of the MDR.
Want to know how you can prepare your clinical data for the EU MDR? Download our whitepaper here.