Emergencies:

(617)-350-2714

Address

920 Aspen Court, Boston 

Clinic Hours:

9:00am – 5:00pm (Mon-Fri) 

Clinic Number

(857)-200-1031

Emergencies:

(617)-350-2714

In Vitro Diagnostic Regulation (IVDR)

In Vitro Diagnostic Regulation (IVDR) is the European Union (EU) law (IVDR 2017/746) that regulates the approval processes for the manufacturers to obtain CE marking for their in vitro diagnostics medical devices (IVDs) so that their devices can be marketed in the EU.

Convenient Healthcare Services

Online consultations

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In-your-home Visits

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Urgent Appointments

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Services and Treatments

Key changes from IVDD to IVDR in respect to ‘’Classification of IVDs’’

The IVDR replaced the existing in vitro diagnostic medical devices Directive (98/79/EC) (IVDD). In terms of their impact on manufacturers and products, the IVDD and the IVDR largely share the same basic regulatory process. No existing requirements have been removed, but the IVDR adds new requirements. The IVDR brings more stringent requirements for the designation of Notified Bodies (NBs), with increased control and monitoring by the national competent authorities and the Commission.

The biggest change concerns the risk classification of in vitro diagnostic (IVD) devices and the role of NBs. The IVDD took a list-based approach to assigning risk classes, which in turn determined the process for assessing conformity and the level of supervision required from NBs. The IVDR instead uses rules recognized at international level to assign each device to one of the four risk categories, ranging from class A (lowest risk) to class D (highest risk). As a result, around 85% of all IVDs will need NBs oversight. For example, the conformity assessment of class D devices will require the involvement of an EU Reference Laboratory (if designated for that type of device) to verify the performance claimed by the manufacturer and compliance with the applicable Common Specifications. For innovative class D devices where no Common Specifications currently exist, an independent expert panel must provide its views on the performance evaluation report of the manufacturer.

The IVDR calls for increased transparency, with information on IVD devices and ‘higher risk’ performance studies being made public. The new European Database for Medical Devices (EUDAMED) will play a central role in providing more complete, accurate and accessible data. Additionally, the introduction of a unique device identifier (UDI) for every IVD device will significantly enhance traceability and support post-market safety activities.

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Key dates for IVDD-IVDR transition

Existing IVDD certificates expire (27 May 2024), All devices placed on the market must be in conformity with the IVDR (27 May 2025).

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What is our role as Requalite in the process?

As an independent Contract Research Organization (CRO) and medical device Regulatory and Quality Consulting company, we provide full service CRO for the clinical performance studies of IVDs and we consult manufacturers of IVDs on the planning, preparation, execution, and reporting of performance evaluations for existing as well as novel IVDs to ensure compliance with IVDR. Requalite prides itself with providing the very best services for planning, writing, and documentation of evaluations and reports provisioned in IVDR. We also provide resources for the manufacturers to help them navigate the system, keep current with the changes in the regulation, and train their personnel responsible for regulatory compliance.

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What do we offer?

  • Performance Evaluation Plan (PEP)
  • Performance Evaluation Report (PER)
  • Literature Search Plan (LSP)
  • Literature Search Report (LSR)
  • Analytical Performance Report (APR)
  • Clinical Performance Report (CPR)
  • State of the Art (SOTA)
  • Post-market Surveillance (PMS) Plan
  • Post-market Surveillance (PMS) Report
  • Periodic Safety Update Report (PSUR)
  • Post-market Performance Follow-up (PMPF) Plan
  • Post-market Performance Follow-up (PMPF) Report
  • QMS in accordance with ISO13485

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Important Client Information

Appointments

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New Patients

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Home Visits

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Prescriptions

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Disability Access

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Emergencies

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Cancellations

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Insurence and Fees

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Online Consultations

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Confidentiality

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