The European Medical Devices Regulation (EU) 2017/745 (MDR) supersedes the Medical Devices Directive (93/42/EWG, MDD) and the Active Implantable Medical Devices Directive (90/385/EWG, AIMDD).
The MDR came into effect in 2017. Its effective date was May 26, 2021, and the transitional provisions will remain in place until December 31, 2028.
How ready is your company?
The requirements for CE Marking of medical devices have significantly changed under the MDR, so companies need to clearly understand their current status and what steps remain to comply with the new Regulation and maintain access to the European market. These checklist questions help you evaluate what you’ve already achieved in preparing for the new regulation and pinpoint areas that need attention to meet the new requirements.
If you answer "no" or aren't sure of your answer to any of these questions, your MDR compliance is likely at risk.
Contact us for assistance on these and other MDR compliance questions. We're currently helping device firms transition into compliance and can help you, too.
1. Does your product fall under the definition of a medical device or accessory under the MDR?
It's crucial to verify whether your product qualifies as a medical device under the Medical Device Regulation (MDR), which may differ from previous classifications under the Medical Devices Directive (MDD). Additionally, check if your product is listed in MDR Annex XVI, which includes products without an intended medical purpose but regulated under MDR.
2. If your device is Class I self-declared, does your QMS address all the elements in MDR Article 10?
For Class I self-declared devices, your QMS must meet all the specific requirements outlined in MDR Article 10, which ensures that manufacturers are adhering to MDR's quality and safety standards.
3. If your device is up-classified from Class I self-certified, and you are taking advantage of the 4-year exemption allowed under Corregendum 2, are you still planning to meet the remaining MDR compliance requirements?
If you are benefiting from the temporary exemption for certain devices, it's important to plan for eventual compliance with the rest of the MDR regulations by 2024, including requirements for QMS, PRRC, and liability coverage.
4. Are you leveraging MDD CE certificates for existing devices? Do you plan significant changes to your devices before the expiry of the certificates?
Manufacturers can still use existing CE certificates under the MDD, but any substantial changes to the device could affect MDR compliance. It's important to plan ahead for certificate expiration and consider updates required for MDR.
5. Are you leveraging MDD CE certificates for existing devices? Do you plan significant changes to your devices before the expiry of the certificates?
Manufacturers can still use existing CE certificates under the MDD, but any substantial changes to the device could affect MDR compliance. It's important to plan ahead for certificate expiration and consider updates required for MDR.
6. Have you performed a gap analysis and identified potential gaps between MDD and MDR?
A thorough gap analysis will help identify areas where your device's compliance under MDD might not meet the stricter standards of MDR, guiding your quality plan for transition.
7. Have you reviewed the compliance of your device to the relevant General Safety and Performance Requirements (GSPR) in MDR Annex I?
Devices must conform to GSPR standards as outlined in MDR Annex I. This includes ensuring you have the necessary testing reports and documented evidence of compliance for each applicable requirement.
8. Does your Clinical Evaluation Report (CER) reflect MEDDEV 2.7.1 rev 4 at a minimum?
CERs must be updated to reflect at least the standards of MEDDEV 2.7.1 rev 4. If clinical data is not included, a rationale must be provided, along with a plan for post-market clinical follow-up (PMCF) to satisfy MDR requirements in Annex XIV.
9. Have you revised your Technical Documentation to meet the requirements in Annex II?
The technical documentation must be updated to comply with MDR Annex II, which outlines what must be included in the documentation for MDR conformity.
10. Have you revised your agreements with your Economic Operators (authorized representatives, importers, distributors) to meet the requirements in Articles 11-14?
Contracts with EOs need to reflect the requirements set forth in MDR Articles 11–14, ensuring all roles and responsibilities are clearly defined, and that appropriate liability coverage is in place proportional to the device's risk class.
11. Do you have a post-market surveillance (PMS) plan reflecting MDR Annex III, specifically establishing a proactive and systematic process to collect any PMS-related information?
MDR mandates a robust PMS plan that systematically gathers post-market data on the safety and performance of devices, helping ensure ongoing compliance with the latest safety standards.
12. Have you identified a person(s) that meet the qualification criteria for the Person Responsible for Regulatory Compliance (PRRC) per Article 15?
A qualified PRRC must be appointed within your organization as required by MDR Article 15, with specific qualifications outlined for this regulatory role.
13. Have you confirmed that your Notified Body will be designated to MDR (including your device(s) codes), or will you need to change your Notified Body?
As Notified Bodies are being re-designated under MDR, it’s crucial to verify that your current Notified Body will still be certified under MDR and will cover the device codes relevant to your products.
14. Do you have a written plan for meeting the MDR requirements by the dates established by Articles 120 “Transitional Provisions” and Article 123 “Entry into force and date of application”?
Planning ahead for the MDR transition is key, with deadlines clearly outlined in Articles 120 and 123. Ensuring a written plan helps to track compliance efforts.
15. Are your QA/RA/audit personnel trained to the MDR? Have you conducted an internal audit to verify compliance?
MDR training for quality assurance (QA), regulatory affairs (RA), and audit teams is essential to ensuring compliance, and conducting internal audits will help verify that all aspects of your MDR readiness are met.
Get Expert EU MDR and IVDR Compliance Support
Are you ready for MDR? Understanding where your company stands with regard to the EU MDR certification process is crucial for meeting regulatory requirements on time and ensuring continued market access.
The FDA Group has helped a wide range of medical device companies efficiently and effectively transition into EU MDR compliance with the help of experienced regulatory experts. We know many, many organizations still need expedited transition assistance, especially as the pandemic has affected preparations to meet deadlines.
These regulations bring significant changes to risk management, clinical evaluation, and operating controls including those for suppliers, general safety and performance requirements (GSPR), labeling, post-market surveillance, and other processes. Simply put, manufacturers must address these areas immediately.
We can help with MDR compliance and help you meet the IVDR.
The FDA Group's EU MDR and IVDR compliance support services include, but are not necessarily limited to:
- Regulatory compliance gap assessments
- Quality Management System (QMS) Assessments for EU MDR & IVDR Compliance
- Assessment for Devices with Valid MDD/AIMD Certificates
- Assessments for Class I devices and systems and procedure packs that must be EU MDR compliant by 2020
- Transition/compliance plan development
- Transition/compliance plan execution
- Knowledge transfer
- File and document maintenance
- Long-term staff augmentation support as needed
The FDA Group's EU MDR and IVDR team has helped many medical device and diagnostic companies—of all sizes—understand these regulations front to back and implement an efficient, comprehensive, and demonstrable approach to compliance.
Whether you need full-service support to develop and execute a compliant regulatory strategy or simply need to augment your internal resources or access additional expertise to manage specific complexities, The FDA Group will deliver the skills and experience you need, when and where you need it.
