Regulis keeps medical device CE marking on track

Regulis applies expert knowledge of EU medical device regulation and achieves a positive opinion from the MHRA on a Class III medical device, despite a flawed study design.


A US-based company developed a class III medical device with an ancillary medicinal product (according to Rule 13, Annex IX of the Medical Device Directive 93/42/EEC). The data were positive in a multi-center, randomised, comparative clinical trial but a prospective protocol-defined primary endpoint was flawed and unfortunately this led to early termination of the study. With the risk of needing to repeat the trial, the company required a partner with specialist knowledge of EU medical device regulations and strong Notified Body experience to avoid a significant delay and costly consequence.


The challenge was to reach a consensus with a Notified Body and Competent Authority on the merits of the study and to prove how, despite early study termination, the clinical outputs were able to demonstrate an acceptable risk/benefit profile for the device, as well as performance attributes in accordance with the intended use.


Using our significant experience of EU medical device regulations and interacting with regulatory authorities,  the regulatory affairs team at Regulis rapidly arranged a meeting with a suitable Notified Body based in the UK for a pre-assessment. Regulis also quickly got to grips with the complexities of the therapeutic area for this novel product and the details of the clinical data to:

  • Carry out extensive pharmacovigilance services, writing a comprehensive Clinical Evaluation Report, Literature Review and Post-Market Surveillance Plan in line with the current Meddev guidance
  • Build a strong case for the safety, performance and usefulness of the device, addressing all variables in multiple sub-group analysis
  • Obtain agreement that the Notified Body would engage services with the Company.

Regulis arranged a scientific advice meeting with the Competent Authority to present the data, which resulted in a positive opinion and the ‘go ahead’ to embark on the CE marking process and large-scale commercial manufacturing campaign to support market launch.


Regulis engagement delivered:

  • A speedy route to CE marking and access to a market worth more than $1 billion
  • No need to repeat an expensive clinical study.

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