The countdown for the EU Medical Device Regulation (MDR 2017/745 EU), what will soon be the only governing EU medical device regulation, is quickly approaching. The compliance deadline of May 2020 may seem quite far away, but with a significant reduction in Notified Body capacity, a sizable increase in demand for regulatory certification services is highly anticipated.
It is expected that the major European Notified Bodies will not likely be designated to the MDR until June 2019 – October 2019. This is just seven (7) to 11 months before the MDR/2017/745 becomes the mandatory European regulation for all medical device manufacturers in the EU.
Upon official designation of EU Notified Bodies under the MDR regulatory framework, these regulatory bodies will likely direct more of their limited internal resources toward the expected tsunami of anticipated MDR 2017/745 conformity assessments. In consequence, device manufacturers are best advised to contact their selected Notified Body of choice and coordinate a regulatory strategy meeting prior to submission of any new MDD applications, or when renewing an existing CE Mark certificate under the MDD 93/42/EEC, as amended.
Manufactures may soon run out of options if CE Mark renewal/transition strategies are not already planned and confirmed with the Notified Body of choice in the next several weeks.
Conformity Planning (Urgent!)
To assist EU medical device manufacturers in their planning, NAMSA has provided the below information from a leading EU Notified Body regarding new MDD submission due dates and CE mark submission timelines in order to meet the May 2020 MDR mandatory compliance date.
| DEVICE CLASS | MDD/AIMD SUBMISSION COMPLETION DATE |
| New CLASS III or AIMD CE submissions* | No later than March 2019* |
| New CLASS IIb MDD CE submissions | No later than May 2019 |
| New CLASS IIa MDD CE submissions | No later than July 2019 |
| New Class I Sterile or Measuring MDD CE submissions |
No later than August 2019 |
*Class III or AIMD submissions requiring consultation should have been submitted before January 2019. Examples are medical products such as, drug-device combination products or devices containing animal tissue derivatives.
Similar time constraints face EU medical device manufacturers looking to renew their existing MDD:M5 medical device certificates in advance of the May 2020 MDR application date. Again, provided below is information from a major Notified Body related to MDD:M5 renewal timelines.
| AUDIT TYPE | AUDIT COMPLETION DATE |
| CE Mark renewal audit, normal certification cycle | No later than May 2019 (NAMSA recommends now!) |
| CE Mark renewal audit for certificates expiring after July 2022 | December 2019 (NAMSA recommends much earlier!) |
It is important to note that legal device manufacturers must COMPLETE their audits by the above dates, and these dates must be confirmed with Notified Bodies as soon as possible. NAMSA considers these dates to be “last minute” and highly recommends that legal manufacturers start the process right now with high priority.
Quality and Regulatory Documentation Requirements
Another important consideration is that manufacturers must have robust quality and regulatory documentation in place such as risk management files and clinical evaluation reports. Any resulting delays in response to audit/technical and clinical review findings may slow the MDD:M5 renewal certification process.
Please be aware that European Notified Bodies cannot issue new or extended MDD:M5 CE Mark certificates regardless of commercial agreements and pending review statuses after May 25, 2020!
Four practical examples of MDD vs MDR certification options are highlighted below:
EXAMPLE 1: DEVICES WITH CURRENT MDD:M5 CE MARKING CERTIFICATE (EXPIRING IN APRIL 2019)
| Renewal options | MDD:M5 Notified Bodies will not be certified to MDR until summer 2019, after current MDD:M5 certificates expire. |
| When to start | Schedule the renewal process now and allocate at least three (3) months for the renewal process. |
| Please consider | MDR certificates must be in place when MDD:M5 certificates expire, no later than May 26, 2024. |
EXAMPLE 2: DEVICES CURRENT WITH MDD:M5 CE MARKING CERTIFICATE (EXPIRING IN SEPTEMBER 2020)
| Renewal options | MDD:M5 or MDR/2017/745. |
| When to start | Schedule the renewal process now and allocate at least three (3) months for the renewal process. |
| Please consider | If selecting the MDD:M5 approval path: recertification audits should be completed prior to May 2019.
No significant design and/or manufacturing changes can be made if renewed within the MDD:M5 framework after May 25, 2020. If choosing the MDR approval route, CE Mark certificates should be acquired prior to July 2020 to allow for safety activities before MDD:M5 certificates expire in September 2020. |
EXMPLE 3: DEVICES CURRENT WITH MDD:M5 CE MARKING CERTIFICATES (EXPIRING IN MARCH 2022)
| Renewal options | MDD:M5 or MDR/2017/745. |
| When to start | Schedule the renewal process now and allocate at least three (3) months for the renewal process. |
| Please consider | If choosing the MDD approval path, recertification audits should be completed by December 2019, and preferably much earlier as no significant changes can be made. If choosing the MDR route, certificates should be acquired before December 2021 to allow ample planning time before certification expiration in March 2022. |
EXAMPLE 4: CE MARKING SUBMISSION FOR A NEW* MEDICAL DEVICES
| Certification options | MDD:M5* or MDR/2017/745. |
| When to start | As Soon As Possible! |
| Please consider | If choosing the MDD:M5* approval path, certification audits should be completed between March 2019 – August 2019, depending on risk classification. NAMSA recommends starting now!
If choosing the MDR route, the conformity assessment procedure must be completed after summer 2019, but before the May 2020 deadline to enable commercial distribution from May 2020 forward. Please contact you Notified Body to discuss, schedule and confirm this pathway now! |
* Important note: Manufacturers of Class I Devices that are NOT sterile, do NOT have a measuring function, are NOT a reusable surgical instrument, and will NOT be reclassified under the MDR, must comply with the MDR requirements from May 26, 20202 forward to legally commercialize in the European Economic Area.
Conclusion
Irrespective of whether medical device manufacturers are attempting to renew a current MDD:M5 CE Mark certificate or planning a complete new conformity assessment application for a new device under the MDD:M5, providing Notified Bodies with adequate notice and communication is imperative for ensuring timely compliance.
It is critical to remember that all designated, remaining EU Notified Bodies will be swamped with CE Mark conformity assessment applications. Manufacturers must take a proactive approach to engage in a focused and timeline-driven plan with selected Notified Bodies as early as possible. This will not only provide manufacturers with detailed feedback and deliverables to help meet tight deadlines, but will also ensure that organizations have appropriately secured CE Mark certificates.
How will Recent EU Regulatory Changes Affect your Organization?
NAMSA’s global regulatory experts welcome the opportunity to discuss strategic options related to the new European Medical Device Regulation (MDR/2017/745) with you. Our teams of EU professionals are available to assist with an in-depth assessment of potential business impacts to your manufacturing business and Notified Bodies/Authorized Representatives.
Learn how a NAMSA-developed contingency plan for the MDR can lead to organizational efficiencies and regulatory success. Please contact us at: communications@namsa.com or +1-419-666-9455. Please also check out NAMSA’s MDR/IVDR planning resources here: https://www.namsa.com/mdr-ivdr-resources/.
Stephan Buttron
Stephan Buttron currently serves as NAMSA’s Senior Product Development Strategist. Mr. Buttron has over 20 years’ experience in achieving EU, U.S. FDA and other international regulatory medical device approvals and registrations. He has provided global consulting services on regulatory strategy development to medical device manufacturers regarding least burdensome pathways for 510(k)/PMA and MMD-CE mark applications. He has successfully managed FDA pre-submission meetings for Investigational Device Exemption (IDE) pathways with multiple FDA specialty branches. Stephan is considered a key industry thought leader on risk management, and has provided multiple training sessions to medical device manufacturers on structured risk management process per EN ISO 14971 & EU MDD 93/42 as amended with directive 2007/ 47. Mr. Buttron has also provided countless educational opportunities to international organizations regarding medical device design and development issues related to ISO 13485 & EU MDD 2007/47 compliance.