EU Regulation 2017/746 (IVDR)
What is IVDR?
In Vitro Diagnostic Medical Devices Regulation (IVDR) is the European Union (EU) law (IVDR 2017/746) that regulates in vitro diagnostics (IVD) market in the EU. Starting on 26 May 2017, the IVDR replaced the the In Vitro Diagnostics Directive (IVDD), which existed since 1998. There is a transition period when IVDD and IVDR will be effective simultaneously. IVDR goes hand-in-hand with and frequently references to the EU Medical Device Regulation (MDR 2017/745), which regulates non-diagnostic medical devices.
Key dates for IVDD-IVDR transition:
26 May 2017: IVDR entered into force
26 May 2022: IVDR will be enforced
26 May 2024: IVDD will expire, IVDs placed on the market thereafter must comply with IVDR
26 May 2025: Deadline for all devices approved with IVDD
What are the key changes from IVDD to IVDR?
A great reset is provisioned with the transition from IVDD to IVDR, where all currently approved IVDs (under IVDD) must be recertified for the new requirements (under IVDR) during the transition period.
Product coverage is expanded in IVDR to include all services that claim to determine a patient’s disease state, predisposition and susceptibility to a disease, or potential benefit from a medical treatment (i.e., genetic, biochemical, physical, or online tests).
Device classification is based on risk classes ranging from Class A (low risk IVDs) to Class D (high risk IVDs). Classification of an IVD is subject to approval by the Notified Body (NB).
Clinical evidence provided by the manufacturers is required to rigorously demonstrate clinical performance and safety of the IVD. Level of evidence is based the IVD’s assigned risk class.
Premarket approval is required for IVDs intended for self-testing or near-patient testing will be subject to a premarket approval
Post-market surveillance is to be conducted by the manufacturer in order to assess and report safety risks periodically.
Technical documentation filed by the manufacturers is subject to more stringent requirements.
Traceability of any instrument is a requirement (through a unique device identification – UDI) for better traceability, assessment, and recall of flawed instruments.
Oversight is more rigorous, including the oversight by the NBs to reduce risks from unsafe devices (i.e., unannounced audits, product checks and testing, annual safety reporting) and greater scrutiny and reduced number of the NBs (currently, five NBs assigned for IVDs).
A qualified person responsible for regulatory compliance of the IVD is to be assigned by the manufacturer.
EU Regulation 2017/745 (MDR)
What is MDR?
Medical Device Regulation (MDR) is the European Union (EU) law (MDR 2017/745) that regulates the approval processes for the manufacturers to obtain CE marking for their medical devices (MDs) so that their devices can be marketed in the EU. Starting on 26 May 2017, the MDR replaced the Medical Device Directive (MDD), which existed since 1998. There is a transition period where MDD and MDR will be effective simultaneously. MDR is frequently used as a reference for the In Vitro Diagnostic Regulation (IVDR) (IVDR 2017/746), which regulates the procedures for a subclass of MDs, in vitro diagnostic devices (IVDs), for diagnostic purposes rather than treatment.
What is our role as Requalite in the process?
We consult manufacturers of MDs on the planning, preparation, execution, and reporting of clinical evaluations for existing as well as novel MDs to ensure compliance with MDR. We provide services for planning, writing, and documentation of clinical evaluations and reports provisioned in the MDR. 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.
Key dates for MDD-MDR transition:
26 May 2017: MDR entered into force
26 May 2021: MDR will be fully enforced
26 May 2024: MDD will expire, MDs placed on the market thereafter must comply with MDR
26 May 2025: Deadline for all devices approved with MDD to be recertified according to MDR
What are the key changes from MDD to MDR?
A great reset is provisioned with the transition from MDD to MDR, where all currently approved MDs (under MDD) must be recertified for the new requirements (under MDR) during the transition period.
Product coverage is expanded in MDR to include some devices that have no intended medical purposes (i.e., cosmetic implant devices and materials, colored contact lenses, etc.). Also reflected in the diagnostic arm, IVDs now include all services that claim to determine a patient’s disease state, predisposition and susceptibility to a disease, or potential benefit from a medical treatment (i.e., genetic, biochemical, physical, or online tests).
Device classification is based on risk, duration of contact with body, and invasiveness. Risk classes range from Class I (low risk MDs) to Class III and implantable devices (high risk MDs) where higher risk classes are subject to higher clinical standards and regular post-market scrutiny. Classification of an MD is subject to approval by the Notified Body (NB).
Common specifications (CSs) will be provisioned by expert panels at the request of the European Commission (EC). Manufacturers and NBs will be required to take these CSs when designing, developing, manufacturing, and assessing MDs for the EU market.
Clinical evidence provided by the manufacturers is required to rigorously demonstrate clinical performance and safety of the MD. Level of evidence is based the MD’s assigned risk class. Class IIa and Class IIb MDs are subject to systematic clinical evaluation.
Post-market surveillance is to be conducted by the manufacturer in order to assess and report safety risks periodically. The process will also include unannounced audits, product sample checks, product tests, and annual safety reporting.
Traceability of any device is a requirement (through a unique device identification – UDI) for better traceability, assessment, and recall of flawed devices.
A qualified person responsible for regulatory compliance of the MD is to be assigned by the manufacturer.
ISO 13485 QMS For Medical Devices
What is ISO-13485?
ISO-13485 is the international standard related to the quality management systems (QMSs) and the requirements for regulatory purposes concerning the medical devices (MDs). ISO-13485 is set out by the International Organization for Standardization (ISO), a worldwide federation of national standards bodies. ISO-13485 specifies requirements for a QMS that can be implemented by an economic operator involved in various stages of the life-cycle of an MD (i.e., the design and development, production, storage and distribution, installation, servicing, and final decommissioning and disposal of the MD and the design, development, or provision of associated activities such as technical support). ISO-13485 can also be used by other parties (i.e., certification bodies) to assess the organization’s ability to meet the relevant customer and regulatory requirements.
ISO-13485:2016 lays out the requirements for the quality management system; management responsibilities; resource management; product realization; and the measurement, analysis, and improvement processes.
ISO 14971 Risk Management
ISO 14971 is an international standard dedicated to medical devices. It determines terminology, the risk management principles, and procedures related to medical devices including in vitro diagnostic medical devices and software as a medical device. ISO 14971 aims to assist medical device manufacturers in determining the hazards associated with medical devices, estimating and evaluating the associated risks, controlling these risks, and evaluating and monitoring the measures’ efficiency. It also guides regulatory authorities to confirm whether manufacturers have passed appropriate risk management procedures to ensure public safety.
ISO 14971 states that the manufacturer must create a risk analysis, risk assessment, risk control, production, and post-production information document used throughout the medical device’s life cycle from design to disposal. Also, ISO 14971 provides information about the management’s expectations, the qualifications of the personnel performing the risk management, the developed risk management plan, and the documentation of the general procedures.
The processes described by the ISO 14971 standard apply to risks associated with a medical device, risks related to biocompatibility, data and system security, electricity, moving parts, radiation, and usability. The processes described in ISO 14971 can also be applied to products included in the medical device lifecycle but are not medical devices.
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