Today, the EU medical device industry reached a major milestone with the arrival of the extended deadline for the application of the European Union Medical Device Regulation (EU MDR 2017/745). Although it is exciting to see this milestone achieved, it does not mean the conclusion for Medical Device Manufacturers. For most, it is an important first step to continue regulatory momentum and to focus on upcoming milestone dates, and to ensure actions are in place to safeguard attaining and maintaining conformity for their devices. These steps will allow manufacturers to maintain availability of devices distributed within the EU market.
From today, May 26, 20201, EU manufacturers must meet the MDR requirements concerning Post-Market Surveillance (PMS), vigilance and registration. This is a requirement for all EU device manufacturers, even if a device has not yet transitioned to MDR and is currently utilizing MDD 93/42/EEC CE Certification for placement on the EU market. In addition to updating relevant Quality Management System (QMS) SOPs, device manufacturers must also create PMS and Post-Market Clinical Follow-Up (PMCF) plans for their devices to generate the relevant data. The Person Responsible for Regulatory Compliance (PRRC) role should also be in place and operational at this time.
It is important to note that no significant changes can be made to devices using a MDD 93/42/EEC CE Certificate to place any medical device on the EU market after today’s date. Making such a change will trigger the transition to the MDR.
Moving forward, all EU manufacturers must follow the requirements set forth within the MDR to gain CE certification for EU market distribution.
Key Milestone Dates for EU Manufacturers to Consider:
- May 26, 2021: EU MDR Date of Application
- May 26, 2021: Placing of UDI-carriers on the labels of devices for Implantable and Class III devices and voluntary compliance with registration obligations (MDCG 2021-1)
- May 2022: Official Launch of EUDAMED
- May 26, 2024: EU MDD Certificates no Longer Valid
- May 26, 2025: Devices Certified under MDD can no Longer be Sold / Distributed
The Good News
Manufacturers still have time to upgrade technical documentation and clinical data to ensure a smooth transition to Notified Body approval and shift to MDR compliance, but it is strongly recommended that action be taken urgently (now!) with the expected logjam of NB submissions as we move closer to 2024.
How can NAMSA Help?
Unsure of the potential impact of current and future milestone dates on your organization’s medical device products? NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device and IVD development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for manufacturers. In fact, many of our Associates have previously held positions within these organizations, which provides Clients the benefit of a clearer understanding on how to proactively plan for international requirements and expectations.
To learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR compliance planning, please visit: https://namsa.com/services/regulatory-and-quality-consulting/.
We also invite you to access our complimentary MDR and IVDR Planning Resources, here.
Adrian Keene
Adrian is Director of EMEA Consulting Services at NAMSA where he utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products. Adrian previously Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In all, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.