The company was privileged to have Arkan Zwick, the Director of Regulatory Affairs at Croma-Pharma, as a distinguished guest speaker at the event. Guided by Irene Lu, who serves as the General Manager for Global Regulatory Affairs at Qualtech, the webinar unfolded with the active participation of 75 attendees.
The European MedTech Market
The webinar kicked off with a spotlight on the thriving European MedTech Market, a dynamic sector worth around €160 billion in 2022, commanding a significant 26.4% share of the global market. This figure positions the EU as the world's second-largest medical device market, with Germany, France, the United Kingdom, Italy, and Spain emerging as their top players.
However, recent shifts in the regulatory frameworks and various political and socio-economic factors in Europe have caused turbulence in this dynamic market.
MDD to MDR: What’s the Big Deal?
The MDR replaced the MDD last 2017, granting a 4-year grace period for alignment. Its goal: improve patient and user safety while pushing innovation and growth in the medical device ecosystem.
Some of the main changes introduced by the EU MDR include:
- • Broader Scope. EU MDR extends coverage to products beyond medical devices and active implantable medical devices, including cosmetic implants and contact lenses.
- • Strict Oversight. Notified bodies (NB) overseeing medical device manufacturers need to comply with more stringent requirements.
- • Tough Conformity Procedures. MDR now requires a Clinical Evaluation Consultant Procedure (CECP), a more rigorous review for certain high-risk devices.
- • EUDAMED Establishment. The MDR aims to facilitate transparency, collaboration, and public access to data on medical devices by establishing the EUDAMED database.
- • Enhanced Post Market Surveillance. The regulation requires manufacturers to collect and report data on the performance and safety of devices throughout their lifecycle.
Although these changes are good, industry players are still in the process of transitioning, even in the present day.
Complication 1: Notified Bodies
The shift to MDR resulted in a decrease of notified bodies. The new regulations were strict, giving a longer and more difficult process for their designation. This shortage in NB causes a delay in the availability and supply of medical devices and IVDs in the EU market. Adding to the urgency, thousands of product certificates need to transition from MDD to MDR. With many of these certificates set to expire this year, the demand for the services of notified bodies is poised to increase substantially,
Complication 2: CECP and Expert Panels
Following the updated classification rules of the MDR, products that fall under Class IIb active devices that administer and/or remove a medicinal product (Rule 12) and Class III implantable devices are all subject to a new assessment called Clinical Evaluation Consultation Procedure (CECP) that is reviewed by the Expert Panels and European Medicines Agency (EMA).
This additional step enhances user safety by providing independent scientific opinions on the clinical evaluation assessment report. However, it also extends the waiting times before registration approval.
The opinions given by the experts are accessible to the public and can be viewed through the European Commission Website.
Complication 3: EUDAMED
The launch of the European Database on Medical Devices (EUDAMED) is experiencing delays due to unforeseen technical and operational challenges. This postponement poses significant concerns for industry stakeholders aiming to comply with the new regulatory framework. Currently, only three of the six crucial modules are operational, leaving critical functionalities like vigilance, clinical investigation oversight, and market surveillance unavailable. This incomplete state not only creates confusion for regulated entities but also hinders the system's potential to enhance transparency and patient safety within the European Union.
An Opportunity: Extended MDR Transition
Fortunately, to avoid the scarcity of essential medical devices for the public due to the aforementioned complications, the European Commission proposed to extend the transition deadlines. This law was formally published on March 20, 2023, in hopes to fully implement MDR within the next four to five years.
According to the EU 2023/607, Article 120(3b) and (3c) is amended as follows:
|
Deadline |
Device Type |
|
May 26, 2026 |
Class III implantable custom-made devices |
|
December 31, 2027 |
Class III devices |
|
Class IIb implantable devices, except certain devices considered ‘well-established technologies’ |
|
|
December 31, 2028 |
Class IIb implantable devices considered ‘well-established technologies’ |
|
Class IIa devices |
|
|
Class I devices placed on the market in sterile condition, having a measuring function or which are reusable surgical instruments; |
|
|
Up-classified devices that require notified body involvement in the conformity assessment. |
To benefit from the extended deadline for EU MDR compliance, manufacturers need to: obtain MDR certification by 26 May 2024 and before their MDD certificate runs out and sign a contract with an MDR-notified body before 26 September 2024.
For more information about the extension, you may visit the official Q&A from the European Commission.
How can Qualtech Support You?
In navigating the intricate landscape of the European Medical Device Regulations (MDR) and ensuring a seamless transition for your medical devices, Qualtech stands as a trusted partner with over 20 years of experience and a track record of over 1000 satisfied clients in Asia. With an impressive tally of 5000+ cases successfully solved, Qualtech is well-versed in the nuances of regulatory compliance and can provide invaluable support throughout the MDR transition process.
Stay informed about updates and webinars! Follow us on Facebook and LinkedIn, or contact Irene Lu (irene@qualtechs.com) for any inquiries.
References:
EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE 'SELL OFF' PERIODS