07.29.15
Officials with Ireland-based Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, report the 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 midsize companies, Acorn Regulatory has put in place a step-by-step process that provides the correct regulatory pathway for medical device products that also have a drug component, according to the company. 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 E.U. authorized representative.
“We have found that, in particular, small to mid-size companies looking for E.U. certification are often intimidated by the complex steps and potential costs in gaining approvals,” said Gemma Robinson, managing director of Acorn Regulatory. “To meet that need, we have streamlined the approach with a process and 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 looking to certify 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 that don’t 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 E.U. certification is why Acorn Regulatory further streamlined its process.
Founded in 2002, Acorn Regulatory helps companies with European regulatory approvals and quality assurance. Acorn regulatory acts as an E.U. authorized representative for medical device and in-vitro diagnostic (IVD) manufacturers, importers and distributors of medical devices, IVDs and pharmaceutical products.
Focusing on small to midsize companies, Acorn Regulatory has put in place a step-by-step process that provides the correct regulatory pathway for medical device products that also have a drug component, according to the company. 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 E.U. authorized representative.
“We have found that, in particular, small to mid-size companies looking for E.U. certification are often intimidated by the complex steps and potential costs in gaining approvals,” said Gemma Robinson, managing director of Acorn Regulatory. “To meet that need, we have streamlined the approach with a process and 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 looking to certify 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 that don’t 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 E.U. certification is why Acorn Regulatory further streamlined its process.
Founded in 2002, Acorn Regulatory helps companies with European regulatory approvals and quality assurance. Acorn regulatory acts as an E.U. authorized representative for medical device and in-vitro diagnostic (IVD) manufacturers, importers and distributors of medical devices, IVDs and pharmaceutical products.