MedDev Day

Moderator: Bassil Akra, Chief Executive Officer at AKRA TEAM GmbH

During this session, key subject matter experts with various competence will share insight on the clinical evaluation consultation process and help attendees understanding the key takeaways from the recent publications of the EU Expert Panels.

It’s becoming clear that the MDR will not deliver its promise of a “sound, transparent, predictable and sustainable regulatory framework” that “ensures a high level of safety and health protection” and “at the same time promotes innovation” as mentioned in the first recital of the MDR.

Therefore, we have to talk about the future of the regulatory medical device system.

The MDR Amendment published in March (Regulation 2023/607) is supposed to remedy the current bottleneck situation and provide more time for the transfer of products to the MDR as a surgical emergency.

However, there remain open questions and further structural problems in the system with the Notified Bodies, which are not solved by the Amendment Regulation.

By mid-2027 the Commission will evaluate the application of the MDR and produce a report on the progress towards achievement of the objectives. This report will reflect the main elements on the future design of the regulatory system.

Industry and Notified Bodies should work together to find solutions, in particular to improve the conformity assessment procedure (e.g. predictable deadlines, calculable costs, equal access to Notified Bodies or System-inherent possibility of complaints, etc.) and to find solutions for missing regulations for innovations, niche products and so-called “orphan devices”.

Regulation EU 2023/607 was published in the Official Journal of the European Union on 20 March 2023. This regulation offered a staggered and conditional extension in the transitional periods of Regulation (EU) 2017/745 (MDR – Medical Devices Regulation) and is also known as the 2nd MDR amendment. In addition, it provided an extension, under certain conditions, to the validity of certificates issued in accordance with Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD) as well as the removal of the sell-off period.

The extension of the MDR has provided longer transition times for devices, while also ensuring continued access to devices currently certified under the directives and that legacy devices do not have to be recalled from their supply chain (unless they expire). However, it has also posed some challenges on its practical implementation by industry and Notified Bodies.

In this session, you will hear about the reasons behind this extension, the operational and practical implementation of the extension by a manufacturer and the impact it had and still has to industry and global market access.

The various stakeholders in the medical device sector were either positively or negatively surprised by the amendment of the EU MDR. Nevertheless, everyone directly understood its necessity and the importance of this additional time for the continuity of the healthcare system in the EU including other countries relying on CE Mark.

During this session, good and bad experience in the implementation of this amended regulation will be shared and discussed.

Article 59(1) is the originally intended route for derogations and it require that the application is made ‘in the interest of public health or patient safety or health’. Most competent authorities are interpreting this narrowly by requiring that there are no alternatives available on the market and that without the device patient health will be compromised.

When is an Article 97 MDR derogation useful?
An Article 97 derogation might be used to take advantage of the extension to the Medical Device Directive (MDD) certificate transition periods in the newly extended legislation if an agreement for a conformity assessment for the specific device has not been put in place before expiry of the certificate.
How to apply Article 97 of the MDR to devices with expired or expiring certificates? How will it work?

You will know more about MedTech industry experience from my presentation

The demarcation between medicinal products and devices is becoming ever more important and, with the convergence of emerging novel technologies, the number of drug/device combination products and medical devices incorporating a medicinal substance is increasing.  Such combinations require an appreciation of the differing regulatory expectations between medicinal products and medical devices and brings together very different worlds.

This session shall provide a Notified Body update on MDR requirements and impacts of MDCG 2020-12 and the consultation process and important considerations when developing such combined products.

Device-drug combinations (DDCPs) are complex products as they require to comply to both drug and device regulations and the conformity assessment procedure involves collaboration of manufacturers, notified bodies and drug competent authorities.

The Medical Devices Regulation (MDR) has a significant impact on the assessment of DDCPs.

First because a justification of the medical device classification based on primary mode of action (PMOA) is to be reconsidered followed by the justification of the drug substance ancillary action.

Second because MDCG guidance requires consultation when moving a DDCP from MDD to MDR.

Third because a clinical evaluation consultation procedure involving European Medicines Agency’s (EMA) expert panels is introduced for class III implants and class IIb active devices administering or removing medicinal products.

The presentation will give an overview on the requirements, steps and challenges governing the compliance of DDCPs with practical insights on how to move legacy DDCPs from MDD to MDR and how to improve interactions between manufacturers, notified bodies and competent authorities to plan and complete conformity assessments in time.