1MED

Enrico Perfler

1MED is a CRO focused on assisting medical device companies in facing the complexity associated with the development of medical devices in compliance with MDR by providing support from a strategic, regulatory, quality, and clinical point of view with a cross-functional approach.

Regulation (EU) 2017/745 (MDR) adopted in Europe represents an important paradigm shift where the patient benefit is at the center: medical device manufacturers are requested to prove the clinical benefit of their medical devices compared to the current State of the Art. To fulfill their goal, medical device manufacturers are asked to define the level of clinical evidence necessary for their products. Further, they are consequently requested to design and implement pre-market studies and post-market clinical follow-up activities to generate clinical data in support of the safety and performance of medical devices for obtaining market approvals from Regulatory Authorities and for CE-mark maintenance.

This paradigm shift posed by the New Regulations for medical devices is not the only challenge for MedTech companies. All CE certificates of medical devices issued following Directives 93/42/EEC (MDD) and 90/385/EEC (AIMDD) will cease to be valid on the 27th of May 2024, at the latest. Therefore, the so-called legacy devices must be recertified under the new European Regulations (EU) before this date to remain on the market.

“Manufacturers’ data generated and collected to date by manufacturers for the certification of medical devices according to MDD/AIMDD may not be sufficient for their recertification under MDR”

The recertification process will require a big effort from the manufacturers, considering the new requirements, especially for the clinical evaluation process (Article 61). The MDR:

• Provides a more stringent definition of “clinical data” (Article 2[48]), and

• Limits the use of equivalence to specific cases (Annex XIV, Part A, pt. 3)

Thereby excluding the use of most of the available data on the device (or its equivalent) to demonstrate compliance with the relevant GSPRs (Annex I).

Manufacturers’ data generated and collected to date by manufacturers for the certification of medical devices according to MDD/AIMDD may not be sufficient for their recertification under MDR.

To support medical device manufacturers in understanding how to move for MDR adoption, 1MED offers a set of consulting services to:

• Systematically analyze clinical data available for each device;

• Timely identify any gap in clinical data supporting the product’s claims;

• Propose solutions to fill identified clinical gaps;

• Define a roadmap with expected times and costs for MDR certification

1MED services are not only limited to MDD to MDR transition. Still, they can encompass all phases of the medical device development lifecycle, starting from pre-clinical phases (device concept, device design, prototyping, bench testing, etc.), through clinical phases (first-in-human studies, pivotal studies, etc.) to post-market activities to monitor device safety and performance when used in real-world (market surveillance and vigilance, post-market clinical follow-up, etc.).

1MED mission, especially towards SMEs, is training medical device companies to ensure a clear understanding of regulatory requirements and team working with clients to support them in the sustainable development of innovative products against the industry’s constraints, mainly identified as the time to market and funds required for their development.