Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, is streamlining procedures for U.S. manufacturers of drug-device combinations with customized programs that successfully overcome challenges in meeting European regulatory approvals.
Focusing on small to mid-size companies, Acorn Regulatory has put in place a comprehensive step-by-step process that provides the correct regulatory pathway for medical device products that also have a drug component. This process includes training programs that first define the requirements, the steps to obtain CE Mark Certification, post-market responsibilities of manufacturers, national requirements throughout Europe and service as an EU Authorized Representative.
“While our work includes support for large multi-national pharmaceutical and device manufacturers, we have found that, in particular, small to mid-size companies looking for EU certification are often intimidated by the complex steps and potential costs in gaining approvals,” said Dr. Gemma Robinson, managing director of Acorn Regulatory. “To meet that need, we have streamlined the approach with an affordable process and a team with a wide range of experience in different product technologies who can offer a customized approach to gain CE Certification and manage post-approval activities. These processes range from training to Quality Management Programs, report writing, electronic submissions, risk management and service as a European Authorized Representative.”
Companies seeking certification for a drug-device combination can face considerable challenges. Due to complexity and risk, they may be subject to additional directives if devices incorporate a substance of animal origin or human blood derivatives. Drug device combinations must comply with the medical device and pharmaceutical directive requirements, which can be an added challenge to small and medium sized companies who do not have expertise in both areas. Determining a device’s status, whether it be drug or medical device, depends on its primary mode of action.
According to Robinson, the complexity of the process and the proliferation of drug-device products seeking EU certification is exactly why Acorn Regulatory further streamlined its process.
“We have cross-functional teams which can offer both the medical device but also the pharmaceutical know-how to ensure that we can obtain the fastest route to market for our clients products,” said Robinson. “We also have live access to Competent Authority portals, and solid working relationships with regulators, all to pre-empt potential obstacles that would ordinarily discourage them from seeking EU certification.”