European Union Regulatory Affairs Flashcards
(28 cards)
What is the EU MDR and when was it fully implemented?
The Medical Device Regulation (MDR) (EU) 2017/745 is the regulatory framework for medical devices in the European Union. It replaced the Medical Device Directive (MDD) with a transition period ending May 26, 2021. The MDR strengthens requirements for clinical evidence, post-market surveillance, and introduces new responsibilities for economic operators.
What is the EU IVDR and how does it differ from the IVDD?
The In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 replaced the In Vitro Diagnostic Directive (IVDD). The IVDR introduced risk-based classification rules (Classes A, B, C, D) instead of the list-based system in the IVDD, strengthened requirements for clinical evidence, and increased notified body oversight for most IVDs.
What does the CE Mark signify on a medical device?
The CE (Conformité Européenne) Mark is a symbol that indicates a product’s compliance with EU health, safety, and environmental requirements defined in relevant directives or regulations. For medical devices, it signifies that the product conforms to the requirements of the MDR or IVDR and can be legally marketed throughout the European Economic Area.
What is a Notified Body in EU medical device regulation?
A Notified Body is an organization designated by an EU member state to assess the conformity of certain products before they are placed on the market. For medical devices, Notified Bodies evaluate whether a product meets applicable regulatory requirements, particularly for higher-risk devices. They can issue certificates allowing manufacturers to CE mark their devices.
What are the risk classifications for medical devices under the EU MDR?
Under the EU MDR, medical devices are classified into four categories based on risk:
- Class I: Low risk (some require notified body involvement for sterile aspects or measuring functions)
- Class IIa: Medium-low risk
- Class IIb: Medium-high risk
- Class III: High risk
Classification is determined using the rules in Annex VIII of the MDR.
What is the Technical Documentation required under the EU MDR?
Technical Documentation is a comprehensive set of documents that demonstrate a device’s conformity with MDR requirements. It includes device description, design information, risk management documentation, verification and validation data, clinical evaluation reports, labeling, and post-market surveillance plans. For Class III devices, it’s called a Design Dossier.
What is Clinical Evaluation under the EU MDR?
Clinical Evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess clinical data pertaining to a device to verify its safety and performance, including clinical benefits, when used as intended by the manufacturer. It’s documented in a Clinical Evaluation Report (CER) and must be updated throughout the device’s lifecycle.
What is EUDAMED?
EUDAMED (European Database on Medical Devices) is a comprehensive IT system established under the MDR to enhance transparency and coordination of information regarding medical devices on the EU market. It includes modules for economic operator registration, UDI/device registration, certificates, clinical investigations, vigilance, and market surveillance.
What is PMCF and why is it important?
Post-Market Clinical Follow-up (PMCF) is the continuous process of updating the clinical evaluation by collecting and evaluating clinical data from the use of a CE-marked device. PMCF is an essential part of the Post-Market Surveillance (PMS) system required by the MDR, aimed at proactively confirming safety and performance throughout the device lifecycle.
What are Common Specifications (CS) under the EU MDR?
Common Specifications are technical specifications adopted by the European Commission that provide a means to comply with the legal requirements for a device, particularly when harmonized standards are insufficient. Manufacturers must comply with CS unless they can justify an equivalent level of safety and performance through alternative solutions.
What is the Basic UDI-DI in the EU regulatory framework?
The Basic UDI-DI is the main access key for device-related information in the EUDAMED database and is referenced in relevant documentation (e.g., certificates, declarations of conformity). It identifies and connects devices with the same intended purpose, risk class, and essential design and manufacturing characteristics, regardless of packaging or commercial presentation.
Which of the following devices would require the most extensive conformity assessment procedure under the EU MDR?
A) Reusable surgical instrument (Class I)
B) Dental filling material (Class IIa)
C) Contact lens disinfection solution (Class IIb)
D) Absorbable surgical suture (Class III)
D) Absorbable surgical suture (Class III)
Class III devices require the most rigorous conformity assessment, including a design dossier examination by a notified body and possibly consultation with expert panels.
Under the IVDR, which of the following IVDs would be classified as Class D?
A) Culture media and buffering solutions
B) Pregnancy self-test
C) HIV blood screening test
D) Blood glucose monitor for self-testing
C) HIV blood screening test
Class D includes high individual and high public risk devices, including those used in transfusion medicine or for determination of life-threatening and highly infectious diseases.
Under the EU MDR, which of the following is NOT considered an economic operator?
A) Manufacturer
B) Authorized Representative
C) Notified Body
D) Distributor
C) Notified Body
Economic operators include manufacturers, authorized representatives, importers, and distributors. Notified Bodies are conformity assessment organizations, not economic operators.
According to the EU MDR, the Person Responsible for Regulatory Compliance must have which of the following qualifications?
A) Medical degree only
B) Diploma in law with 2 years of experience
C) Diploma in relevant scientific discipline with 4 years of professional experience
D) MBA with 1 year of regulatory experience
C) Diploma in relevant scientific discipline with 4 years of professional experience
The MDR requires either a university degree in law, medicine, pharmacy, engineering, or another relevant scientific discipline with at least 4 years of professional experience, or 10 years of professional experience without such qualification.
Outline the main conformity assessment pathways for medical devices under the EU MDR.
- For Class I (non-sterile, non-measuring):
- Self-declaration of conformity
- Technical documentation preparation
- For Class Is, Im, Ir, IIa, IIb, III:
- Selection of appropriate conformity assessment route
- Notified Body application
- QMS audit by Notified Body
- Technical documentation assessment
- For Class IIa: representative sampling
- For Class IIb: representative sampling (more extensive)
- For Class III: full review of technical documentation
- Issuance of certificates by Notified Body
- Declaration of conformity by manufacturer
- CE marking of device
Describe the key components of the Post-Market Surveillance (PMS) system under the EU MDR.
- Post-Market Surveillance Plan
- Active data collection methods
- Trend analysis processes
- Indicators and thresholds for benefit-risk evaluation
- Post-Market Surveillance Report (PMSR) for Class I
OR
Periodic Safety Update Report (PSUR) for Classes IIa, IIb, and III - Post-Market Clinical Follow-up (PMCF)
- PMCF Plan
- PMCF Evaluation Report
- Vigilance System
- Incident reporting
- Field Safety Corrective Actions (FSCAs)
- Trend reporting
- Integration with Risk Management
- Continuous update of risk assessment
- Implementation of risk control measures
A manufacturer has a Class IIb orthopedic implant with 5 years of clinical data. Under the MDR, they are planning to claim equivalence to a similar device to supplement their clinical evidence. What considerations must be addressed?
- The equivalent device must have a valid CE certificate
- The manufacturer must demonstrate technical, biological, and clinical equivalence
- Access to the equivalent device’s technical documentation must be secured via contract
- Differences between devices must be fully analyzed and justified
- Equivalence alone is likely insufficient for a Class IIb implant; own clinical data must still be primary
- A PMCF plan must be implemented to collect additional long-term data
- The clinical evaluation report must be updated at least annually for this device class
A company is developing an AI-based app for stroke risk assessment in the EU. What specific MDR requirements would apply?
- Proper classification (likely Class IIa or higher depending on risk)
- Implementation of full quality management system
- Fulfillment of General Safety and Performance Requirements (GSPRs)
- Software-specific documentation including:
- Software development life cycle documentation
- Architecture design charts
- Software requirements specifications
- Risk management with cybersecurity considerations
- Verification and validation including clinical validation
- Creation of specific UDI for the software
- Post-market surveillance system with special attention to software updates
- Consideration of MDCG guidance documents on software qualification and classification
What are the economic operators under the MDR and what are their key responsibilities?
Economic operators under the MDR include:
1. Manufacturers: Design, produce devices and ensure MDR compliance
2. Authorized Representatives: Represent non-EU manufacturers and verify compliance
3. Importers: Verify compliance before placing devices on EU market
4. Distributors: Verify compliance of devices they distribute
Each has specific obligations for documentation, vigilance, and traceability, with joint liability provisions increasing the importance of proper oversight and agreements between parties.
What is the Person Responsible for Regulatory Compliance (PRRC) and what are their key duties?
The PRRC is a mandatory role within manufacturer and authorized representative organizations under the MDR. Their key duties include:
1. Ensuring conformity of devices is appropriately checked before release
2. Ensuring technical documentation and EU declaration of conformity are maintained
3. Ensuring post-market surveillance obligations are complied with
4. Ensuring reporting obligations for vigilance are fulfilled
5. Ensuring statement regarding investigational devices is issued
The PRRC must have requisite expertise in regulatory affairs and device regulation.
What are the key differences between a Custom Procedure Pack and a System or Procedure Pack under the MDR?
A Custom Procedure Pack is assembled to a specific medical prescription for an individual patient, while a System or Procedure Pack is a commercial combination of CE-marked devices to be used together.
Key differences:
- Custom packs require specific labeling with patient identification
- System/procedure packs have simplified regulatory requirements if only combining CE-marked products
- System/procedure packs must have a verification process ensuring compatibility
- Different documentation and declaration requirements apply to each type
What is the MDR Article 120 legacy device provision and how can it be used strategically?
Article 120 allows devices with valid MDD certificates to continue being placed on the market until certificate expiration (but no later than May 26, 2024) if:
1. They continue to comply with the MDD
2. No significant changes in design or intended purpose occur
3. MDR requirements for post-market surveillance, vigilance, and registration are followed
Strategic use involves:
- Maximizing MDD certificate validity periods before transition
- Carefully planning any design changes to avoid triggering MDR compliance
- Developing a comprehensive transition plan with timeline and resource allocation
Which approach would be most strategic when planning a clinical investigation for a novel Class III implantable device in the EU?
A) Conduct a single-arm study in the EU only
B) Conduct a pivotal randomized controlled trial designed to meet both EU and US requirements
C) Rely primarily on literature and equivalence to avoid clinical investigation
D) Conduct a limited EU study and supplement with post-market clinical follow-up data
B) Conduct a pivotal randomized controlled trial designed to meet both EU and US requirements
Designing a clinical study to meet requirements in multiple major markets is more resource-efficient and provides stronger evidence for both regulatory approval and market adoption. For Class III implantable devices, comprehensive clinical data is required in both regions.
