FAQs on EU MDR 2017/745: Key Insights for Medical Device Companies
Do you have questions related to the EU Medical Device Regulation (MDR)?
In this blog, we have answered some of the frequently asked questions (FAQs) on EU MDR, specifically relevant to medical device companies.
We hope this blog answers the most common questions while enriching you with everything you need to know about EU MDR.
1. What is EU Medical Device Regulation (EU MDR 2017/745)?
The EU Medical Devices Regulation (EU MDR 2017/745) is a set of rules established by the European Union (EU) that ensure medical devices marketed within the EU are safe and effective.
The MDR (Regulation (EU 2017/745) replaced the previous directives — the EU Medical Devices Directive (93/42/EEC MDD) and the Active Implantable Medical Devices Directive (90/385/EEC AIMDD) — when it was adopted on 5 April 2017, implemented in May 2017 and the applicability of MDR took effect on 26 May 2021.
In order to safeguard patients and users and maintain a healthy medical device market, the new MDR regulation enforced more stringent evaluations to ensure medical device quality, safety, and performance.
2. When was the EU MDR regulation implemented?
The EU MDR entered into force in May 2017, and became fully applicable on May 26, 2021.
3. When did the EU MDR take effect?
The EU MDR was originally set to take full effect in May 2020, with a three-year transition period for compliance.
Due to the COVID-19 pandemic, this date was extended to May 26, 2021. From that date, new medical devices in the EU are mandated to meet the new MDR requirements.
However, some MDR provisions had to be postponed until December 2028 for devices approved under the directives (MDD and AIMDD) or covered by a Declaration of Conformity issued before May 26, 2021.
4. How are the MDR requirements different from the MDD/AIMDD?
The new EU MDR regulation differs from MDD/AIMDD in the following manner:
⦿ Product scope expansion: The new EU MDR covers more types of medical devices, also including those without an intended medical purpose.
⦿ Comprehensive classification of devices: Annex VIII of the EU MDR requires devices to be classified based on risk, contact duration, and invasiveness. The new classifications can be stricter, requiring some devices to meet stringent requirements. The EU MDR brings greater clarity by explicitly including medical devices that are purely software within its scope, ensuring they are properly regulated based on their intended use and risk. With the introduction of dedicated classification rules, especially Rule 11 where Software as a Medical Device (SaMD) is now clearly defined, medical devices are subject to more structured regulatory requirements.
⦿ Stricter conduct of clinical evaluation for Class III and implantable devices: Medical device companies face significantly stricter clinical evidence requirements They must also collect and retain post-market clinical data to monitor potential safety risks.
⦿ Systematic clinical evaluation for Class IIa and IIb devices: Medical device companies must present strict evidence of equivalence requirements to determine if clinical investigations are necessary.
⦿ More stringent documentation: Annexes II and III of the EU MDR require medical device companies to provide detailed technical documentation. The documentation must include design control data, device descriptions, manufacturing information, performance requirements, risk assessments, safety necessities, and validation. The documentation must be clear, organized, and searchable.
⦿Person responsible for regulatory compliance(PRRC): Medical device manufacturers must designate at least one qualified individual responsible within the organization for ensuring compliance with EU MDR requirements. Special provisions may apply to small businesses and startups.
⦿ Unique Device Identification (UDI): Devices must have a UDI for better traceability and recall in case of safety risk. The EUDAMED database has been expanded for more efficient access to device information.
⦿ Increased surveillance by notified bodies: Notified bodies will conduct more rigorous post-market surveillance, including unannounced audits and product testing, to reduce risks from unsafe devices. Medical device companies/ manufacturers must provide annual safety and performance reports in many cases.
⦿ No exemptions for devices: All devices, including those previously certified under the MDD or AIMDD, must be recertified under the MDR by December 2028 to continue being legally sold in the EU.
5. Why did the EU MDR propose an extension of the transition period?
The European Commission proposed extending the transition period for the Medical Devices Regulation (MDR) (EU) 2017/745 due to several factors which primarily includes the following:
- Limited Notified Body Capacity: Despite the rapid progression of EU Medical Device Regulation implementation, the notified bodies still have a limited capacity. This limitation poses a problem in a successful transition to the new framework.
- Manufacturer Preparedness: Many medical device companies are unprepared to meet the Medical Devices Regulation requirements by the end of the transition period.
- Potential Device Shortages: Failure on behalf of medical device companies to comply with the new regulation means lesser availability of medical devices in the EU market. The supply of medical devices could be severely disrupted in the absence of legislative action, which would have an effect on European healthcare systems and patient care.
Check more details on the EU MDR transition in the blog –
MDR Extension: Navigating the Latest Changes in European Medical Device Regulations
6. What are the different transition periods based on types of devices?
The extension of transition periods varies based on device risk levels.
⦿ May 26, 2026: Deadline for Class III custom-made implantable devices.
⦿ December 31, 2027: Deadline for higher-risk products (Class III and Class IIb implantable devices, except specific items like sutures and dental products).
⦿ December 31, 2028: Deadline for medium and lower-risk products (other Class IIb devices, Class IIa devices, and Class I devices).
Extensions depend on product safety, and medical device companies meeting transition deadlines must submit their application by May 26, 2024.
However, Class I devices not needing MDR certification and new/formerly uncertified devices must comply with MDR requirements from May 26, 2021.
Check the full story: Extension to EU MDR transition period finalized!
7. Are there any postponements in the application of the entire EU MDR Regulation?
No. Since May 26, 2021, the EU Medical Devices Regulation has been in force and has not been amended in its entirety. Only the transitional provisions have been amended to provide extended timelines, thus allowing manufacturers and notified bodies additional time to meet the new requirements under certain circumstances.
8. Which medical devices or products can benefit from the extension?
The extension applies to:
⦿ Legacy devices: Devices covered by a valid certificate or declaration of conformity issued under Council Directives 90/385/EEC or 93/42/EEC before 26 May 2021.
This includes devices such as pacemakers and syringes.
However, such devices must maintain compliance with the previous directives, have no significant changes in design or intended purpose, and do not pose an unacceptable risk to health and safety. Medical device companies must have already taken steps to transition to the new EU Medical Devices Regulation to benefit from it.
⦿ Class III custom-made implantable devices: These devices, like patient-specific implants for bone reconstruction, are provided an extended transition period until 26 May 2026.
Similar to legacy devices, medical device companies must have already taken steps to transition to the Medical Devices Regulation (MDR) to benefit from this transition.
Furthermore, they must submit an application for MDR certification by 26 May 2024 and sign a contract with the notified body by 26 September 2024.
9. Will extending the transition periods affect public health or patient safety?
No, rather, it will benefit public health and patient safety.
The extended transition periods will have more rigid conditions to ensure only safe devices, and those whose manufacturers are already transitioning to the Medical Devices Regulation get more time.
10. What are the main benefits of the EU MDR for patients?
The EU Medical Device Regulation (MDR) provides several key benefits for patients, including:
⦿ Better traceability: Implementation of a unique device identifier (UDI) system to ensure notified bodies can track medical devices easily.
⦿ Enhanced safety: Stricter pre-market scrutiny for high-risk devices with expert review ensures greater patient safety.
⦿ Financial compensation: A robust mechanism ensures patients are compensated for damage caused by defective devices.
⦿ Greater transparency: A comprehensive EU database (EUDAMED) improves transparency of medical device information.
⦿ Implant card: Patients with implanted devices receive an ‘implant card’ with essential information.
⦿ Improved coordination: Better coordination among EU countries on vigilance and market surveillance.
⦿ Improved oversight: Reinforced criteria for the designation and oversight of notified bodies.
⦿ Inclusion of aesthetic devices: Certain aesthetic devices with similar risk profiles to medical devices are now regulated.
⦿ Post-market surveillance: Strengthened requirements for manufacturers’ post-market surveillance.
⦿ Stronger clinical evidence: Enhanced rules for clinical evidence and coordinated EU-wide authorization for clinical investigations.
11. What EU MDR implications do medical device companies need to comply with?
Medical device companies must comply with the following EU MDR implications:
⦿ Conduct regular audits and inspections for compliance.
⦿ Conduct thorough clinical evaluations and investigations.
⦿ Designate a PRRC (Person Responsible for Regulatory Compliance).
⦿ Ensure compliance with General Safety and Performance Requirements (GSPR).
⦿ Ensure proper labeling and Unique Device Identification (UDI) for traceability.
⦿ Establish a system for reporting serious incidents and field safety corrective actions.
⦿ Implement a comprehensive quality management system.
⦿ Implement post-market surveillance and vigilance activities.
⦿ Maintain up-to-date technical documentation.
⦿ Obtain certification from a Notified Body for applicable devices.
You can learn more about these implications in detail from the EU MDR official website.
12. What is a "significant change" under MDR transitional provisions, Article 120?
Under the EU MDR Transitional Provisions, Article 120, a “significant change” refers to alterations in a device’s design or intended purpose that would require reevaluation under the MDR rather than the previously applicable directives (MDD or AIMDD).
In general, minor modifications that don’t affect performance, safety, or the device’s intended use aren’t regarded as significant. These could include small revisions to the device’s labeling or usage guidelines that don’t affect how the device works or is used.
The significant changes as per the new EU medical device regulation include the following:
⦿ Design changes: Design changes refer to the modifications related to materials, design features, or technological characteristics that impact the device’s safety and performance.
⦿ Intended purpose changes: It refers to any alteration in the use or indication of the device. For instance, if a device originally intended for one type of surgery is now intended for a different type or additional uses, this would be significant.
⦿ Changes impacting compliance: Any modifications that could affect the device’s compliance with the essential requirements or its conformity with the General Safety and Performance Requirements (GSPR) of the MDR are the Changes impacting compliance.
If a significant change is made, the device is no longer eligible to benefit from the transitional provisions under Article 120 and must undergo full MDR conformity assessment before it can continue being placed on the market. MDCG 2020-3 “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD” provides deeper insights on this.
13. What is the role of Notified Bodies in the MDR?
Notified bodies play a vital role in assessing and ensuring conformity for medium and high-risk medical devices. The EU Member States appoint and oversee while the national authorities monitor these independent third-party establishments.
Since 2013, joint teams from other Member States and the Commission have conducted assessments of these bodies. The new framework strengthens this successful joint assessment process for the designation and monitoring of the notified bodies.
14. Why are there so few Notified Bodies?
Notified bodies are mostly private, profit-driven entities. The EU MDR imposes stricter requirements on notified bodies, which affects how long it takes for them to be designated.
The exact number of Notified Bodies designated under the EU Medical Devices Regulation (MDR) can be obtained from the European Commission’s NANDO (New Approach Notified and Designated Organisations) database. This database provides the most current and authoritative information on Notified Bodies.
15. When must the number of the Notified Body appear on Class I reusable devices?
Devices classified as Class I measuring function (Im) devices, reusable surgical instruments (Ir), and sterile device (Is) under the MDD did not need a Notified Body’s involvement. However, under the MDR, these devices do require it. They can be placed on the market until 31 December 2028 under the amendment Regulation (EU) 2023/607, provided the conditions for the extended transition period are met. After this date, they need MDR certification and labeling with the notified body’s number. However, it does not apply to Class I devices without a current MDD certificate or those that do not need an MDR certificate. The extended transition period is conditional. Extra time is granted only for safe products, and manufacturers must have started the transition to MDR. However, to benefit from the extension, manufacturers should have submitted a formal application for MDR conformity assessment by 26 May 2024.
16. Do medical device companies need to recall Class I reusable devices to re-label them?
No, Class I reusable devices placed on the market under the MDD before the MDR’s start date(26 May 2021). do not need to be recalled for relabelling purpose. Generally, devices lawfully placed on the market under the MDD or AIMDD before the MDR date of application can continue to be made available or put into service until 31 December 2028, provided specific transitional provisions under Article 120 of the MDR and Regulation (EU) 2023/607 are met. Under the MDR, reusable surgical instruments are now classified as Class Ir, requiring Notified Body involvement for conformity assessment and labelling. However, the extension of the transition period until 2028 applies only if:
- The device continues to comply with the MDD
- No significant changes in design or intended purpose are made
- The device remains safe
- By 26 May 2024, the manufacturer had submitted an application to a Notified Body for MDR conformity.
- By 26 September 2024, a written agreement with the Notified Body was signed.
Therefore, no recall is required for MDD-compliant Class I reusable devices already placed on the market, but MDR requirements will apply for continued market placement beyond the transition deadlines.
17. Where can I learn more about EU MDR regulation?
You can learn more about the EU MDR from their official website.
18. How can medical device companies prepare for the EU MDR?
You can get a detailed overview of how to prepare for EU MDR from our comprehensive guide. You can also visit www.elexes.com or schedule a free consultation today.
19. How does the EU MDR impact certification costs?
Implementing the EU MDR and the auditing processes requires significant effort from Notified Bodies.
These efforts lead to an increase in operational costs, which are reflected in higher service fees for manufacturers. Notified bodies also need to reorganize and expand their resources to meet the growing demands for conformity assessment, further raising certification costs.
Moreover, the EU MDR mandates stricter regulatory oversight, necessitating more frequent assessments, which contribute to increased certification expenses over five years.
Additionally, you may want to look at our List of Frequently Asked Questions about CE Marking.
20. Will deleting the ‘sell-off’ date allow low-quality devices to stay on the market longer?
Low-quality devices cannot be kept on the market for longer just because the “sell-off” date has been removed. The purpose of this modification is to avoid shortages and needless disposal of safe medical devices. This clause will only apply to devices that have been lawfully placed on the market by complying with EU safety regulations. The safety of these devices will also be ensured by measures like post-market surveillance and the reporting of significant incidents. As a result, even after their expiration date, devices with a short shelf life must be withdrawn regardless of the removal of the sell-off period.
21. What is the present situation of the EUDAMED medical devices database?
EUDAMED is a European database designed to enhance the traceability and transparency of medical devices within the EU. Following are the six modules that will be covered:
⦿ Actor registration
⦿ Clinical investigations
⦿ Device registration
⦿ Notified bodies and certificates
⦿ Unique device identification (UDI)
⦿ Vigilance and market surveillance
Currently, the modules for actor registration, UDI/device registration, and certificates/notified bodies are available.
The remaining modules and some additional functionalities will be released once EUDAMED is fully operational. The European Commission is working closely with Member States to complete this complex project. EUDAMED will become fully functional and mandatory, with a corresponding notice published in the Official Journal of the EU.
22. What is being done to ensure full implementation of the MDR?
To guarantee that the Medical Devices Regulation (MDR) is implemented successfully, the European Commission and the Medical Device Coordination Group (MDCG) have taken a number of steps.
Some of the key measures include:
⦿ MDCG position papers and guidance: The MDCG has endorsed 19 non-legislative actions (as outlined in MDCG 2022-14) to enhance notified body capacity and manufacturers’ preparedness. The commission has also issued position papers on hybrid audits and appropriate surveillance. Furthermore, they have revised guidance to remove obstacles to hiring qualified personnel by notified bodies.
⦿ Delegated acts: The EU Commission adopted acts to defer the first complete re-assessment of notified bodies, freeing up capacity for designating authorities and notified bodies to handle the transition. For further details, please refer to MDCG 2022-13 – Designation, re-assessment, and notification of conformity assessment bodies and notified bodies.
⦿ EU4Health program support: The EU commission introduced a new program – ‘EU4Health’ for better implementation of health related initiatives. The EU4Health program funds actions to support notified bodies and SMEs, improve coordination between Member States on market surveillance, assess regulatory governance, survey market actors, support orphan medical devices, and strengthen coordination between notified bodies.
⦿ Enterprise Europe Network: The Enterprise Europe Network was launched by the EU commission to raise awareness of regulatory requirements and provide targeted support to SMEs in the medical devices sector.
The implementation of remaining actions from MDCG 2022-14 continues, with a temporary uniform approach to market surveillance measures to bridge gaps between expiring and new certificates.
Conclusion
Medical device manufacturers may find it challenging to comply with the EU Medical Device Regulation (MDR), which requires stricter post-market surveillance, more comprehensive documentation, and adherence to clinical evidence standards.
A global regulatory consultant can streamline and expedite this process by offering knowledgeable advice on regulatory requirements, helping with documentation and clinical evaluations, and guiding the certification process with notified bodies.
This support helps you efficiently transition to MDR compliance, ensuring your devices meet the new standards while minimizing disruptions to their market access.
Looking for seamless MDR compliance? Contact Elexes’ expert team today at http://elexes.com/contact.
