Facility, Product & Directive to Regulation Gap Analysis

Directive to Regulation

MDD EU MDR

The transition from the Medical Device Directive (MDD 93/42/EEC) to the Medical Device Regulation (EU MDR 2017/745) introduces more stringent requirements for demonstrating the safety, performance, and quality of medical devices. As MDD certificates expire, manufacturers must ensure compliance with MDR to maintain access to the European market.

A gap analysis is an essential first step in the transition process. It helps identify deficiencies in existing documentation, processes, and quality management systems compared to MDR requirements, enabling organizations to develop an effective compliance strategy.

MDR gap analysis includes the review of

• Technical documentation
• Clinical Evaluation Reports (CER)
• Risk management documentation
• Labels and Instructions for Use (IFU)
• Post-Market Surveillance (PMS) and PMCF documentation
• Supplier and distributor details
• Product testing and validation records
• Vigilance and regulatory procedures

By identifying compliance gaps early, manufacturers can streamline MDR implementation, reduce certification delays, and ensure continued market access within the European Union.

IVDD IVDR

The transition from the In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC) to the In Vitro Diagnostic Medical Devices Regulation (IVDR (EU) 2017/746) represents a significant enhancement of the regulatory framework for IVD devices. The IVDR aims to improve patient safety, strengthen clinical evidence requirements, and increase transparency throughout the product lifecycle.

A gap analysis is a critical first step in achieving IVDR compliance. It helps identify differences between existing IVDD-compliant documentation and the new regulatory requirements, enabling manufacturers to establish a clear transition plan.

IVDR gap analysis includes the review of

• Device classification based on the new risk-based classification system
• Product scope and regulatory applicability
• Scientific validity, analytical performance, and clinical performance evidence
• Technical documentation requirements
• Risk management and quality management systems
• Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
• Labeling and Instructions for Use (IFU)
• Compliance with Common Specifications (CS), where applicable
• Vigilance and regulatory reporting processes

Conducting a comprehensive gap analysis helps organizations identify compliance gaps early, prioritize remediation activities, and ensure a smooth transition to IVDR while maintaining access to the European market.

Facility Gap Analysis

If you are setting up a medical device manufacturing facility upgrading an existing one or getting ready, for ISO 13485 certification, CE marking or regulatory inspections we give clear guidance to help you stay compliant.

What do we assess?

• Facility Infrastructure: Layout, production areas, utilities, lighting, ventilation, and maintenance.
• Material and Personnel Flow: Movement of raw materials, components, finished products, personnel, and waste.
• Environmental Controls: Temperature, humidity, cleanliness, contamination control, and cleanroom controls, where applicable.
• Manufacturing Processes: Process controls, work instructions, in-process inspections, and traceability.
• Equipment Management: Installation and operational qualification, calibration, maintenance, and equipment records, as applicable.
• Cleaning and Contamination Control: Cleaning procedures, housekeeping, contamination prevention, and cleaning validation, where required.
• Sterilization and Packaging: Applicable sterilization controls, packaging operations, validation records, and environmental conditions.
• Storage and Material Management: Identification, segregation, storage conditions, stock rotation, and material traceability.
• Quality Management System: Document control, training, nonconformity management, CAPA, supplier control, and change management.
• Health, Safety, and Supporting Infrastructure: Relevant workplace controls that may affect product quality or the applicable regulatory requirements.

Setting up a medical device or an IVD manufacturing facility can be challenging. MEDREG offers onsite Facility Gap Analysis services to help manufacturers evaluate their existing infrastructure, manufacturing processes, quality systems and operational controls with respect to requirements.

We go to manufacturing facility to examine practices, areas that do not meet regulations and suggest practical fixes. Our assessment shows exactly what needs to be improved so that facility matches requirements and relevant standards.

Product Gap Analysis

Is your medical device or IVD ready for regulatory approval?

Our Product Gap Analysis service helps manufacturers identify gaps between their existing product documentation, technical requirements, and applicable regulatory requirements before initiating a conformity assessment or regulatory submission.

We conduct a systematic review of product's regulatory status, intended purpose, classification, technical documentation, risk management, clinical or performance evidence, biological evaluation, verification and validation, labelling, and applicable standards to identify missing documents, insufficient evidence, and areas requiring improvement.

MEDREG’s Approach

• Review: Evaluate existing product characteristics, documentation and available technical evidence.
• Identify: Missing documents, compliance deficiencies, and areas requiring additional justification or testing.
• Assess: Prioritize identified gaps according to regulatory significance and potential impact on product compliance.
• Recommend: Provide practical recommendations and corrective actions to address each identified gap.

Don't wait for a Notified Body assessment or regulatory review to discover the gaps in your product. Identify them early.