Regulatory Compliance
Regulatory Compliance Consulting
MEDVACON provides a host of Regulatory Compliance consulting Services. Our Regulatory experts possess comprehensive knowledge of the Code of Federal Regulations and are prepared to assist you with your Regulatory Compliance Consulting needs. Our experience provides us with a unique understanding of the impact of federal regulations on your business operations. Our experts can provide in-depth assessments of your company’s compliance levels and help get products to market quickly.
MEDVACON offers a comprehensive menu of cost-effective solutions and helps our clients traverse the landscape of regulatory requirements and language and to mitigate the risks associated with operating in a regulated industry.
EU MDR & IVDR Planning
The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, sets forth new and important requirements for medical device and in vitro diagnostic manufacturers that distribute products in the EU. The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) of Medical Devices 2017/746 is impacting the IVD industry at all levels.. Under this directive, all products, regardless of class, that stay on the market following the transition date of May 26, 2022 must be reassessed for IVDR compliance to ensure that products are fit for purpose and safe for use.
When do Medical Device Manufacturers Need to Comply to The New IVDR?
Starting May 26, 2022 new devices will have to meet the requirements of the IVDR in order to be placed in the European market. Products already certified by a Notified Body may be placed on the market until 25 May 2024 under some conditions and if the manufacturer fulfill the specific prerequisite requirements drawn in the IVDR.
What Are Some Key Changes?
The biggest change from IVDD to IVDR is the introduction of a risk-based approach to classification in addition to increased NB oversight. The Regulation identifies four new risk classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk) aligned with IMDRF/GHTF IVD classification guidance. Under the current regulations, most IVDs are self-certify, thus a NB does not have to review the technical file. There are very few delays. With IVDR most IVD will not be self-certified and instead will fall into Class B, C, and D IVDs which will require NB intervention as part of their conformity assessment. Technical files and clinical evaluation reports that have been used for years. Medical device companies will need to be revised to meet the new regulations. This will also increase the strain on NB resources, in addition to the extra work caused by the MDR.
Here’s a quick look at some of the key provisions included in the IVDR:
- Expanded product scope
- More rigorous clinical safety and performance evidence
- Device reclassification according to risk (see previous paragraph)
- Pre-market approval of self-testing and near-patient testing devices
- More stringent technical file documentation
- Identification of “person responsible for regulatory compliance”
- Implementation of unique device identification
- Increased post-market surveillance requirements
- Reduced general timeline reporting
- More rigorous surveillance by NBs
- Greater scrutiny of NBs
- No device “grandfathering”
MEDVACON Can Assist Medical Device and IVD Manufacturers With Compliance Planning and Execution
MEDVACON IVDR Transition Steps:
- Gap Assessment – Prior to beginning an IVDR initiative, organizations should first evaluate their current state with a MEDVACON Gap Assessment to know what must be done to achieve compliance. Once the gap assessment is completed and you have a complete understanding of the scope of your initiative, it’s crucial to identify a MEDVACON team leader and team members to remediate the gaps and achieve compliance.
- IVDD to IVDR Transition Plan – It is important that you develop a transition plan for your IVD products taking the following into account: availability of Notified Body resources; the expiration timing of any existing CE certificates; the need for obtaining CE certification prior to the compliance date for those many newly classified products; and internal staffing or consultant availability to handle increased workload. There are many IVD products that do not currently have a CE certificate that will require one for IVDR compliance.
- Importers, Distributors, and Authorized Representative Increased Responsibilities – As the manufacturer, you must make sure that your EU Authorized Representative, importers, and distributors are all ready to assume their new obligations, which include adding information to the EUDAMED database.
- IVDR Training – The new IVDR contains many changes, even for experienced IVD medical device professionals so it is important to train your staff so everyone understands the requirements and the plan for meeting them.
Example Projects
Regulatory Compliance CE Mark Submission Drug Dossier Development
A client developing drug-eluting bioresorbable coronary scaffolds for the treatment of cardiovascular disease, the leading cause of death worldwide engaged MEDVACON to assist the firm in preparing a drug dossier required for CE Submission in Europe. Specifically, MEDVACON’s scope of services was to: Review program and current status; Review requirements for a drug module going to MHRA; Organize communication and next steps; Set initial assignments and requirements for a given section; Update work remaining and subsequent planning; Upon completion of the module provide final review and comments to client team.
Regulatory Compliance Annual Report Development
MEDVACON’s client is a pharmaceutical company whose mission is not one of drug discovery but rather that of acquisition and commercialization of prescription products that will satisfy unmet clinical needs in specialty therapeutic areas. This “virtual company” outsources the manufacture, pharmaceutical development, packaging and testing of their products. MEDVACON was enlisted to provide Regulatory Compliance assistance to support the development of Annual Reports for submission to the client’s eCTD submission vendor. Specifically MEDVACON reviewed submission documents and prior Annual Reports to assemble the submission materials and prepare the submission form.
Biopharmaceutical Regulatory CMC Services Consulting
A biopharmaceutical company specializing in applying deuterium chemistry to known molecules to create novel therapies with the potential for improved safety and efficacy profiles engaged MEDVACON in the area of Regulatory Compliance Consulting. Client enlisted MEDVACON to assist in bringing their product from development to market. Specifically MEDVACON provided assistance with ensuring regulatory requirements were addressed and specifically ensure all elements of the CMC section were accurately represented. The product received FDA approval and MEDVACON remains engaged overseeing CMC and Clinical Supply activities.
Combination Medical Device - Pharmaceutical Regulatory Compliance Consulting - Example 1
MEDVACON’s client is a combination Pharmaceutical- Medical Device manufacturer engaged in emergency care treatment options into the hands of military and civilian defenders for more than 50 years. Our client is committed to help defend against critical, time-sensitive, life-or-death situations by providing medical countermeasures to the United States Department of Defense, Emergency Medical Services, Homeland Security, and more than 30 nations around the world. Client engaged MEDVACON to assist in Root Cause Analysis and remediation of FDA findings.
