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MDR Extension
The extension of Medical Device Regulation (MDR) deadlines under (EU) 2023/607 (Ref. MDCG 2021-25 for additional guidance) has led many manufacturers to breathe a sigh of relief.
With additional time granted for compliance, some organizations may feel a reduced sense of urgency.
But does this extension truly mean manufacturers can afford to wait? Not exactly. While the new timelines offer flexibility, they come with specific conditions and ongoing requirements for quality management system (QMS) remediation.
Now is the time to take a strategic approach and leverage information to streamline remediation to address Stage 1 or Stage 2 MDR nonconformances.
Project Triangle Reality: Resources vs Scope
In the middle of EU 2023/607 Preamble Paragraph (4), the resource bottleneck of having trained auditors to perform conformity assessments was recognized as an issue:
“Despite the steady increase in the number of notified bodies designated in accordance with Regulation (EU) 2017/745, the overall capacity of notified bodies is still not sufficient to ensure the conformity assessment of the large number of devices covered by certificates issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC before 26 May 2024”
While auditing resources are added, this does not mean compliance requirements have eased. The extension only applies under certain conditions, including:
- Device(s) have a EU 93/42/EEC (MDD) certificate that were still valid on 26 May 2021and that have expired before 20 March 2023
- Manufacturers must be engaged with a competent authority of a Member State to carry out the applicable conformity assessment procedure
- There are no significant changes in the design and intended purpose,
- No later than 26 May 2024, the manufacturer has put in place a quality management system in accordance with Article 10(9);
Description Date the manufacturer has put in place a quality management system in accordance with Article 10, including transitional requirements May 26, 2024 for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function. December 31, 2028, Class IIb implantable and Class III devices, excluding well established technologies December 31, 2027 Class IIb implantable and Class III devices, including sutures, staples, dental fillings, orthodontic appliances, dental crowns, screws, wedges, plates, guides, pins, clips and connecting devices December 31, 2028 Products without an intended medical purpose (Ex: contact lenses), the product was on the market before 22 June 2023 June 22, 2025 - Before the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement for the conformity assessment in respect of the device covered by the expired certificate or in respect of a device intended to substitute that device.
- The contract between a notified body and a manufacturer shall include the following requirements (Ref. EU MDR Section 4.3, second subparagraph, of Annex VII):
- take the form of a written agreement signed by both parties,
- kept by the notified body.
- have clear terms and conditions and contain obligations that enable the notified body to act as required under this Regulation, including an obligation on the manufacturer to inform the notified body of vigilance reports,
- the right of the notified body to suspend, restrict or withdraw certificates issued and the duty of the notified body to fulfil its information obligations.
- The contract between a notified body and a manufacturer shall include the following requirements (Ref. EU MDR Section 4.3, second subparagraph, of Annex VII):
MDR Article 10(9): More than ISO13485 Compliance
Many manufacturers wonder: Are the Article 10(9) and transitional requirements the same as ISO 13485?
The answer: Not quite. While ISO 13485 forms the foundation of a compliant QMS, MDR Article 10 includes additional specificity and requirements, such
| Article 10 Requirement | Description of Change | Helpful Link |
| setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83 | Implement a closed loop post market surveillance process and meet transitional requirements, including annual post-market surveillance deliverables | >Quality Plan for Transitional Requirements
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| clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF | Implement clinical evaluation requirements to support a closed loop post market surveillance system | Clinical Deliverables Link |
| verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29 | The Unique Device Identification (UDI) System allows the identification of medical devices, facilitates appropriate traceability of medical devices, enhances the effectiveness of the post-market safety-related activities for devices, leads to better surveillance, reduces medical errors, and helps identify falsified devices. | UDI Implementation Plan Template-MDR – QMS Velocity
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| identification of applicable general safety and performance requirements and exploration of options to address those requirements | Regulatory Watch and
Standards Watch to identify state of the art requirements and associated impact assessments to evaluate the risk during transition to new requirements. |
Normative/Standards Watch-MDR – QMS Velocity
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Why Wait? Start Your Compliance Journey Today
While the MDR extension grants additional time, manufacturers should act now to avoid last-minute remediation challenges. Our ready-to-go solutions, developed through successful implementations across EU and non-EU manufacturers and two Notified Bodies, help companies:
- Understand exactly what to do and when to do it
- Follow a structured remediation process to avoid unnecessary complexity
- Implement a streamlined approach to compliance—without overloading internal resources
Don’t let the extension create a false sense of security. By acting now, manufacturers can ensure compliance, risk mitigation, and business continuity—well ahead of the deadlines.
Explore our solutions today: MDR Phase 1 – QMS Velocity
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