On 16 February 2023, the European Parliament voted to adopt an amendment that affects Article 120 and Article 110 of Regulations (EU) 2017/745 and (EU) 2017/746, respectively. The amendment only extends the transitional period for legacy medical devices, but also removes the sell-off period for both medical and in vitro diagnostic (IVD) devices.
The sell-off period is the end date after which devices already on the market, but not yet with the final user, should be withdrawn. The removal of the sell-off period allows devices already certified under the MDD/IVDD/AIMDD, which are in the supply chain, to be made available for as long as the product shelf-life allows. This will reduce the risk of device shortages and prevent unnecessary disposal of safe medical devices already on the market but not yet with the final user.
New timelines and conditions are summarized in the following table:
| Type of Certificate | New Dates | |
| AIMD/MDD certificates that were valid on 26 May 2021 and are currently valid (i.e. not withdrawn/expired) shall remain valid beyond their certificate expiry date, until the following dates:
|
Class III and IIb implantable except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors. | 31 Dec 2027 |
| Class IIb devices (other than those covered above), class IIa devices and class I devices placed on the market in sterile condition or having a measuring function. | 31 Dec 2028 | |
| AIMD/MDD certificates that were valid on 26 May 2021 and have expired before the extension of the MDR transitional period came into force shall be considered valid (and continue to place devices on the market) if one of the following conditions are met:
|
a) Before the date of certificate expiry:
The manufacturer has signed a written agreement with a Notified Body for the device or for a device intended to substitute the MDD certified device. |
See applicable dates above. |
| b) A competent authority of a Member State has granted a derogation under Article 59(1) or has required the manufacturer, under Article 97(1), to complete the applicable conformity assessment procedure (MDCG 2022-18). | ||
| Not certified under the MDD and the Declaration of Conformity was drawn up prior to 26 May 2021. | Class I Reusable | 31 Dec 2028 |
| Not certified under the MDD—custom-made. | Class III custom-made implantable devices | 26 May 2026 |
The Notified Body that issued the MDD/AIMD certificate will remain responsible for ongoing audit surveillance of the manufacturer, unless otherwise agreed upon with the Notified Body conducting the MDR conformity assessment. Until 26 September 2024, the Notified Body conducting the MDR conformity assessment will become responsible for the device covered by the written agreement, or the substituted device. The transfer of surveillance will need to be addressed within the written agreement between the manufacturer and the Notified Body conducting the MDR conformity assessment, and where practical, the MDD/AIMD certificate issuing Notified Body.
What are the requirements to comply with during the transition period under Article 120, including the new 2023 amendment?
Manufacturers of legacy devices are still required to comply with the MDR requirements related to:
- Vigilance, including the reporting of serious incidents and field safety corrective actions (Articles 87 and 89) and trend reporting (Article 88).
- Post-Market Surveillance (PMS), including the drawing up of a PMS and Post-Market Clinical Follow-Up (PMCF) Plan according to Articles 83 to 86).
- Registration for Economic operators and devices (Articles 29 and 31).
Those manufacturers that would like to benefit from the new timelines must ensure that:
- Devices continue to comply with Directive 90/385/EEC or Directive 93/42/EEC.
- Devices do not present significant changes in the design and intended purpose.
- Devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.
- No later than 26 May 2024, the manufacturer has put in place a Quality Management System (QMS) in accordance with Article 10(9) of the MDR. It is not sufficient to only have procedures in place, there needs to be evidence of implementation of the QMS.
- No later than 26 May 2024, the manufacturer, or an authorised representative, has lodged a formal application with a Notified Body for conformity assessment in respect of a device, or in respect of a device intended to substitute that device.
- No later than 26 September 2024, the Notified Body and the manufacturer have signed a written agreement to conduct an MDR conformity assessment.
How does this amendment affect manufacturers?
There are several points manufacturers should focus on if they would like to benefit from the transitional period:
- Manufacturers need to continue to transition to the MDR with speed. They will still need to be able to apply for MDR certification by 26 May 2024 and have an MDR compliant QMS. The extension allows for more time for the certification process, but there is still a cut-off date for applications that manufacturers need to meet. Now is not the time to take the foot off the gas regarding MDR.
- Ensure the MDR requirements relating to PMS, market surveillance, vigilance and registration of economic operators and of devices are being met, and that the Periodic Safety Update Reports (PSURs)/PMS reports are available to demonstrate that the device does not present an unacceptable risk to the health.
- Maintain compliance activities related to maintenance of the MDD/AIMD certification and audit surveillance.
- Reconsider commercial strategy relating to production and device stockpiling in light of the continued market access once the extended period is over.
- Take the opportunity to continue developing clinical evidence for legacy devices via PMCF.
- It is important to remember that this change only affects the timelines, not the technical content expected under the MDR, so continued diligence in meeting the more granular requirements is needed.
What is the impact on the United Kingdom Conformity Assessment (UKCA) process?
On 20 February 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a communication concerning the impact of extending the transition period in the EU.
The MHRA is carefully considering the implications of these revisions for the acceptance of CE-marked medical devices on the Great Britain (GB) market. At present, a device with a valid CE mark can be placed on the GB market until 30 June 2023. That includes certificates valid under the latest EU’s revised transitional arrangements. There are plans to extend acceptance of the CE marking in GB, which will be put into UK law in the coming months. The MHRA will publish guidance on this as soon as possible.
These changes made to the MDR will apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol.
How can NAMSA help?
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 experts communicate with EU entities nearly every day and are the most experienced in the industry at accelerating regulatory submissions and approvals for manufacturers. Many of our Associates have previously held positions within these organizations, which provides Clients with the benefit of a more precise understanding of how to proactively plan for international requirements and expectations.
NAMSA is here to assist in the all aspects of MDR/IVDR transitioning, and many other areas of EU medical device development:
- Do you need help with your MDR/IVDR transition strategy and documentation?
- Do you require support to establish an MDR/IVDR compliant QMS?
- Do you require assistance generating PSURs/PMS reports in order to demonstrate the safety requirements for the extension?
- Do you need assistance with your MDR/IVDR application?
To learn about NAMSA’s full suite of Regulatory and Quality services and solutions, including MDR/IVDR compliance planning, visit: https://namsa.com/services/regulatory-and-quality-consulting/.
We also invite you to access our complimentary MDR and IVDR Planning Resources, here.
Dr. Rachel Gibbs, PhD, BSc
Rachel Gibbs has 15 years of experience in the medical device and pharmaceutical industry and also as a senior auditor for a leading European Notified Body. Rachel started her career at the MHRA working on drug variation and renewal licensing, before moving back into academia to conduct a PhD in Immunology. Thereafter, Rachel moved into the pharmaceutical industry, joining 3M Healthcare, working on the development of metered dose inhalers and nasal sprays for FDA and EMEA drug applications. With the opening of 3M’s Skin and Wound care laboratory, Rachel transitioned into the medical device industry, and was actively involved in New Product Development for a range of wound care devices, where she specialized in design control, risk management, manufacturing upscaling and process validation. Rachel moved to BSI in 2015 as a senior auditor and clinical evaluation specialist involved in product conformity assessment to the Medical Device Directive (93/42/EEC) and subsequently audits against the Medical Device Regulation ((EU) 2017/475). Rachel joined NAMSA in 2021 and has used her knowledge of MDR auditing to advise clients regarding their regulatory and clinical strategies, undertaking gaps assessments and writing MDR submission documents.
Dr. Arancha López-Pérez
Dr. Arancha López-Pérez has a strong scientific background with a PhD in Biosciences and close to ten years of experience in scientific research. During her academic career, she focused on the development of in vitro assays for drug screening against Multi-Resistant Bacteria. Dr. López-Pérez’s medical device industry experience includes working as Regulatory Affairs Scientist and Quality Assurance, and she has expert competence in the European regulatory landscape (MDR 2017/745, IVDR 2017/746 and the MEDDEV/MDCG guidance documents). She is a certified ISO 13485 Lead Auditor with experience in setting up medical device quality management system standards aiming to support manufacturers placing and maintain their devices in the market, including the IVDD/MDD to IVDR/MDR transition. She also provided regulatory support on clinical projects gaining thorough knowledge in the design, set-up and conduct of clinical investigations according to ICH/GCP guidelines, ISO 14155 and ISO 20916.