If you are a medical device manufacturer (MDM) or work in a support industry to the global medical device market, you are probably familiar with the date May 15, 2020. It is then that the three-year transition to the Medical Device Regulations (MDR) governing document (adopted by European Parliament in 2017), comes to a close. Every MDM that markets products in the EU is impacted by the MDR.
The previously governing Medical Device Directive went into effect in 1993. The 2017 MDR presented two significant conditions that did not exist in 1993. Addressing these critical gaps would shape how the industry is governed going forward, specifically 1) the introduction (and subsequent explosion) of technology and software as intrinsic to the use of medical devices, and 2) the demand for transparency, technical information and traceability. These overarching needs and patient safety concerns have ushered in and will continue to impact the approval process for all MDMs serving the EU market.
The transformative nature of the MDR and its fast-approaching deadline comes with many questions. Wherever your organization lies on the spectrum of awareness and implementation of the stringent new requirements, we’ve curated some resources that may help you assess your readiness and plan the next steps.
- Will MDR implementation be delayed by the US FDA?
- A perspective on the top four challenges under the MDR and IVDR
- Foundational guidance from the European Medicines Association
- Questions to ask your internal team and partnering up to prepare
Oliver Healthcare Packaging will continue to track and report on noteworthy MDR developments.
