Regulatory Compliance Services

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.

​Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do, some more frequently than others. The more comprehensive and structured the investigation process is, the more effective it will be. While CAPA is handled differently at many pharmaceutical manufacturers, best practices for handling complaints and investigations revolve around certain core activities, a basic process and, more often than not, some enabling technology. MEDVACON's Team of Quality Investigation and CAPA experts can assist your company in achieving Quality Investigation compliance. 

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.  

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. 

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 IVDR Transition Steps:

1. 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. 
2. 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.
3. 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.
4. 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.