CROMSOURCE Regulatory specialists are delighted to offer a broad range of services to medical device, pharmaceutical, and biotechnology companies. We have extensive experience of regulatory document preparation together with the management of client-focused projects with a strong record of successful outcomes. We provide timely strategic advice to facilitate our clients’ product development and lifecycle maintenance helping them make their product a commercial success.
Country Specific Requirements for Clinical Projects
We maintain a Clinical Studies Submissions Database (CSSD) with comprehensive information relating to study requirements and procedures for medicinal products and medical devices in all European countries, the US, Canada and more than 15 countries worldwide. This includes information on relevant legislation/regulation, sequence of submissions to Competent Authorities and Ethics Committees, timelines, notifications, fees, and lists of documents required. Leveraging CROMSOURCE’s global presence, our regulatory intelligence professionals access, summarise, and assess global regulatory intelligence to ensure submissions are compliant with regional and local requirements.
• Consultation on legislation and country specific requirements for clinical studies with medicinal products and medical devices.
• Liaison with National Competent Authorities, Ethics Committees, Institutional Review Boards, EU Notified Bodies, Health Canada, and the US FDA, including providing advice and preparing dossiers and applications.
• Tailored training in Regulatory Affairs – legislations, regulations, and local requirements.
Clinical Evaluation of Medical Devices in Europe
Medical Devices Regulation (MDR)
Medical device manufacturers have three years to update their technical documentation and processes in order to meet the requirements of the new regulation. Any new medical devices will need to be certified in accordance with the new MDR regulations. Existing Medical Devices Directive (MDD)-certified medical devices have an additional transition period until May 2024 to change their technical documentation to comply. After May 2025, devices certified under the MDD can no longer be sold or distributed.
CROMSOURCE’s regulatory specialists can perform a comprehensive Gap Analysis on clinical evidence for devices requiring MDR certification and identify products that may require additional clinical investigations or Post-Market Clinical Follow-up (PMCF) studies. New MDR Post-Market Surveillance (PMS) requirements must be implemented along with requirements for PMCF or justification of why PMCF is not required.
Clinical Evaluation Reports (CERs)
The CER is an important document that forms part of the technical documentation submitted for CE-marking of each medical device. In June 2016, revision 4 of MEDDEV. 2.7.1 “Guidelines on Medical Devices: Clinical Evaluation – A Guide for Manufacturers and Notified Bodies” was published. This raised the standards on the rigor expected in terms of how clinical evaluations are conducted and reported, and has resulted in more intense scrutiny by Notified Bodies. CROMSOURCE’s regulatory team has extensive experience of regulatory writing and CER preparation for a wide range of devices to MEDDEV 2.7.1 rev 4. The team reviews and evaluates the customer’s documentation and provides guidance regarding identified issues to ensure that the clinical evaluation demonstrates conformance with relevant Essential Requirements. Notified Bodies have accepted CERs written by CROMSOURCE’s CER team according to MEDDEV 2.7.1 rev 4.
Regulatory Support for All Stages of Product Lifecycle in the US and Europe
In the US, the FDA is the regulatory authority that oversees public health by assuring the safety, efficacy, and security of drugs, biological products, combination products, and medical devices. CROMSOURCE regulatory experts in the US work in concert with clients to determine the most expeditious way to market their products for commercial success.
CROMSOURCE has a successful FDA submission track record with investigational and marketing applications for medical devices.
In Europe, the EU Member States have different National Competent Authorities (NCAs) which plays an essential role in the protection of public health by assuring the quality, safety, and efficacy of medicines, Advanced Therapy Medicinal Products (ATMPs), and medical devices. CROMSOURCE regulatory experts in Europe have an established robust regulatory strategy with all NCAs to allow for accelerating start-up and study approvals.
CROMSOURCE supports our clients through the entire classification and application processes from development to registration and ultimately post-approval management.
CROMSOURCE’s Regulatory Intelligence team:
• Detects changes and provides surveillance in the regulatory national specific requirements for MDR compliance;
• Supports decision-making in the context of proposed regulatory pathways for clinical investigations and evaluations under the MDR;
• Provides timely and efficient communications with clients, supported by a comprehensive regulatory database and library.
CROMSOURCE’s regulatory team provides expert guidance and advice in the following areas:
• Regulatory Newsletter to stay current on country, regional, and global clinical trial regulatory requirements and changes;
• US Agent and Regulatory Liaison for communications;
• Establishment registration and device listing;
• Small Business Certification for reduced user fees;
• Preparation support for Pre-Sub (Q-Sub), SIR’s, Informational Meetings, FDA and Competent Authority meetings, negotiations, responses, communications, and rehearsals;
• 513(g) Request for Information Submissions;
• IDE and IDE maintenance;
• 510(k), PMA;
• De Novo petition and application;
• eCopy compliant submissions;
• User fee payments;
• Regulatory pathways for clinical investigation under the MDR and preparing and submitting the Clinical Evaluation Report and Clinical Evaluation Plan.
CROMSOURCE’s regulatory team provides support in the following areas:
• Strategic Regulatory Consulting and Regulatory Pathways;
• Regulatory Gap Analysis, review, and remediation of regulatory documents;
• Provide regulatory strategy, planning, and guidance from device development to commercialisation covering multiple device classifications and therapeutic areas;
• Device development and regulatory pathways to market in the EU and US;
• Implementing and transitioning to Medical Devices Regulation (MDR) with Assessments and regulatory strategy development;
• Intended use statement and IFU development;
• Regulatory and literature review to determine classification and predicate device to support submissions;
• Regulatory advice and pathways for pre-clinical protocol design for investigational devices;
• Request for Designation (RFD) for Combination Products;
• Medical Device advertising, promotion, marketing, and labelling;
• Consultation for Clinical Investigations and Post-Market Clinical Follow-up (PMCF) and PSUR studies;
• CE Mark strategy and interfacing with Notified Body;
• Regulatory submission preparation of the regulatory position for new therapies, medical specialties and medical technologies.
• Expert regulatory consulting team for regulatory intelligence and regulatory affairs
• Collating and analysing regulatory requirements of any product category
• Submission document management and tracking
• Regulatory content management
• Regulatory support across multiple markets and countries worldwide