Following the release of the Medical Device Coordination Group (MDCG) guidance 2021-24 on 4 October, 2021, MDCG published additional guidance, MDCG 2021-25 Regulation (EU) 2017/745, dated 21 October, 2021. This document discusses the application of MDR requirements to ‘legacy devices’ and devices placed on the market prior to 26 May 2021, in accordance with Directives 90/385/EEC or 93/42/EEC.
This MDCG guidance is the output of the taskforce created to discuss and identify legally defendable and pragmatic solutions to address the application of MDR requirements to ‘legacy devices’ and devices placed on the market before the MDR Date of Application (DoA) 26 May 2021, according to the Active Implantable and Medical Device Directives (AIMD and MDD). The publication of the guidance is welcome by industry stakeholders as it removes some areas of uncertainty for both manufacturers and Notified Bodies. However, its late publication may lead to significant changes for both manufacturers’ MDR implementation plans and Notified Body(NB) activities and expectations.
The key takeaways from this most recent MDCG guidance are as follows:
- Clarifies the requirements laid out in Article 120 (3) – Transitional Provisions
- Reiterates of the definition of ‘legacy devices’ provided in MDCG 2021-13, i.e., devices that carried CE certification under MDD or AIMD and are now being placed on the market during the transitional period between the DoA May 2021 until 26 May 2024. These are devices with valid CE Certification issued under the AIMDD and MDD before 26 May 2021 or Class I devices declared by the manufacturer before 26 May 2021, which under the MDR, now require Notified Body approval.
- Reiterates the definition of ‘old devices’ from MDCG 2021-13 – devices that were placed on the market prior to DoA 26 May 2021 according to the MDD or AIMD, but are no longer being placed on the market during the transition period.
- Defines “MDR devices” as those being placed on the market in conformity with the MDR other than legacy devices, i.e., devices that now conform to MDR requirements in their entirety, not just Article 120 provisions.
- Confirms that Post-Market Surveillance (PMS), vigilance and market surveillance requirements from Chapter VII of the MDR apply to all legacy devices and that Notified Bodies shall ‘take into account’ these post-market requirements at surveillance audits.
- Defines that PMS requirements within the post-market surveillance report for Class I devices (Article 85) and Periodic Safety Update Reports (PSURs) for all other classes of devices (Article 86) should be based on existing classification under the MDD, and not on any possible change in classification under the MDR.
- Note: AIMD devices should be considered Class III when applying MDR requirements during the transitional period.
- Outlines that PSURS must be available to Competent Authorities upon request, as well as for Notified Bodies within the surveillance audit framework. Notified Bodies should utilize the PSUR to verify that the approved quality system and design remain compliant with the existing MDD or AIMD certificate. However, the addition of the PSUR for Notified Body review during surveillance audits should not justify an amendment to existing contracts or extra fees to a manufacturer.
- Defines the non-PMS requirements for Economic Operators; the most surprising is that the person responsible for regulatory compliance (Article 15 PRRC) is not required for manufacturers with only legacy devices utilizing the Article 120 transition period.
- The PRRC requirement only applies to devices in conformity with the MDR.
- It should be noted that there is nothing to prevent an Economic Operator from choosing to use PRRC requirements for both legacy and MDR devices, if preferred.
- Examples of other provisions not applicable to legacy devices are:
- Article 16 (3 and 4) importers and distributors QMS provision and indicating activities and details on devices or packaging, as well as communication to competent authorities on repacked/relabeled devices
- Article 18 – Implant Cards
- Article 25 – Identification within the supply chain
- Article 27 – UDI (also refers to MDCG 2019-5)
- Article 32 – Summary of Safety and Clinical Performance
- Outlines how systems and procedure packs (Article 12 of the MDD) containing only legacy devices can utilize the transition period requirements.
- However, systems and procedure packs combining legacy and MDR devices must apply Article 22 to the MDR devices, while the legacy devices included fall under the transitional period requirements.
- Although Competent Authority market surveillance activities still apply, MDR requirements do not apply to ‘old devices’.
- Finally, the MDCG also provides a helpful table (described as ‘non-exhaustive’) of MDR requirements applicable or not applicable to ‘legacy devices.’
How Can NAMSA Help?
Unsure of the potential impact of MDCG 2021-24 or 2021-25 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.
Paul Risborough holds the position of Principal Regulatory Consultant at NAMSA. Until recently, Paul worked as the Global Head of Active Implantable Medical Devices at BSI, Notified Body, overseeing the Medical Device compliance of Active Implantable Medical Devices. Before becoming a Manager at BSI, Paul was an Active Implantable Device Technical Specialist, Scheme Manager and ISO 13485 Auditor. Previously, Paul worked as an electronics design engineer, project leader, and engineering manager involved in designing and manufacturing syringe pumps, large volume pumps; RF, ultrasonic, and gas plasma surgical tools; needle-free injectors, and SpO2 meters. Paul has an education in Systems Engineering, BEng (Hons).