Obtaining CE marking is a mandatory step for medical device manufacturers entering the European Union (EU) market. The CE mark is essential to assure patients that the devices available in the market are both safe and effective for use. A critical component of providing this assurance involves conducting a thorough examination of the technical documentation for medical devices.
Devices categorized under the European Union Medical Device Regulation (EU MDR) 2017/745 Class I (except Class I sterile/reusable surgical instruments/measurable function) and the In Vitro Diagnostic Regulation (IVDR) 2017/746 Class A are exempted from undergoing technical assessment through a Notified Body (NB). However, it is mandatory for Class IIa/IIb medical devices and Class B/C IVDs to undergo a comprehensive technical assessment conducted by the respective NB.
Let us now understand what medical device technical assessment documentation is and how it is related to the sampling of devices.
As stated earlier, the evaluation of technical documentation plays a crucial role throughout the lifecycle of medical devices. This meticulous review primarily takes place during the pre-market phase, when Regulatory authorities scrutinize comprehensive documentation provided by manufacturers to verify compliance with rigorous standards and regulations. This process is indispensable for acquiring or preserving market access for medical devices.
The term “sampling of devices” denotes a systematic procedure for choosing representative samples of medical devices to carry out the assessment. This sampling process stands as a vital element within the EU MDR technical documentation of a medical device, and it is necessary for ensuring Regulatory compliance.
Sampling Plan
NBs are responsible for preparing the sampling plan for the assessment of technical documentation for MDR Class IIa/IIb and IVDR Class B/C devices. The sampling plan generally contains details on the certified devices, including their basic Unique Device Identification-Device Identification (UDI-DI); the generic device group (for Class IIb); the combination of the generic device group and IVP code, which applies to vitro diagnostic medical devices that require specific knowledge in examination “Procedures” for the purpose of product verification (for Class C devices); or the category of devices (for Class IIa/ Class B devices). Additionally, it should specify the identifier for the relevant technical documentation, the scheduled assessment dates, and the status of these assessments.
Sampling of Devices During Surveillance
During surveillance audits for Class IIa/IIb and Class B/C IVDs, NBs are obligated to assess technical documentation on a representative basis. Considering the vast range of medical devices and IVDs, NBs follow a representative sampling approach to evaluate technical documentation. That is to say, instead of examining every device, they assess the technical documentation for a representative group of devices based on their classification. Let us now take a closer look at the range of devices covered and the process of representative sampling.
Device Range Coverage
For Class IIa and Class B IVDs, NBs must go through the technical documentation for at least one (01) device per category of the medical device. A category is a group of medical devices that share similar characteristics and intended uses. This, in turn, suggests that NBs do not have to assess the technical documentation for every single device under a specific category, but rather, they must assess at least one (01) of the devices to ensure that all the devices under that category meet the Regulatory requirements.
For instance, in the case of Class IIa surgical instruments, NBs do not need to evaluate the technical documentation for each surgical instrument under the category. However, they are obligated to assess the technical documentation for at least one (01) device to ensure that all the surgical instruments under this category adhere to the Regulatory requirements.
On the other hand, in the case of Class IIb and Class C IVDs, NBs must evaluate the technical documentation for at least one (01) device per generic device group. A generic device group comprises devices that share the same technical concept and serve similar intended purposes.
Let us consider a case of a molecular diagnostic test for a specific infectious disease; here, it is not necessary for the NB to scrutinize the technical documentation for every individual test under this category. However, the NB is required to rigorously assess the technical documentation for at least one (01) representative device under this category.
Representative Sampling
NBs are responsible for ensuring that the sampled devices are proportionate to the total number of devices specified in the certificate. It is expected that 15% of devices from each category and each generic device group will undergo assessment during its validity period (up to five [05] years).
Duration of Sampling Assessment
As part of the annual surveillance assessment cycle, a minimum of one (01) set of technical documentation must undergo review each year. The NB will guarantee that each device is sampled only once during the certificate’s validity period unless specific concerns arise that necessitate re-sampling.
Evaluation of the Technical Documentation
The following aspects are considered for the review of the technical documentation:
- Device Usage: This examination focuses on the intended application and operation of the device to ensure alignment with the Regulatory requirements.
- Biocompatibility Assessment: This assessment scrutinizes the device’s compatibility with biological systems to verify that it poses no risk to patients.
- Clinical Evaluation: This involves the review of clinical data and evaluation reports to ensure the device’s safety and performance in a clinical setting.
- Performance Evaluation: Technical documentation must demonstrate the device’s intended performance, which is evaluated through the established sampling plan.
- Risk Management: Processes and documentation related to identifying, evaluating, and controlling risks associated with the device are thoroughly scrutinized.
- Sterilization Validation: In cases where applicable, the review includes methods and validation of sterilization processes to ensure compliance with the necessary sterility standards.
- Design Conformity: This assessment helps ensure that the design of the device aligns with the specific Regulatory requirements.
All these elements cited above collectively undergo a comprehensive review, thereby ensuring that the device complies with the relevant Regulatory standards.
Exceptional Scenarios
Under certain circumstances, NBs might grant an exception to the established sampling criteria. For instance, an exception might be considered if a medical device is a novel device or if there is a limited body of experience with the device. NBs typically grant exceptions to sampling criteria in the following scenarios:
- Novel Device: When the device is a novel type of medical device, an exception can be granted, which allows for a more comprehensive assessment of its unique features and characteristics, along with potential risks.
- Limited Experience with the Device: If there is only limited experience with the device, an exception can be granted, which would, in turn, allow the collection of additional data to ensure a thorough evaluation.
- Small-quantity Manufacturing: For devices manufactured in small quantities, an exception may be considered in order to allow the limited production volume.
- Limited Patient Population: When the device is intended for a specific patient population, an exception may be granted to allow sole focus on the relevant safety and efficacy for the target users.
Manufacturers must submit a formal request for an exception to the NB. This request should include a detailed justification outlining the motive behind the exception and providing relevant supporting information pertaining to the device. The NB will then thoroughly evaluate the request and decide whether to grant an exception to the device.
As mentioned earlier, CE marking for medical devices mandates a thorough evaluation of the technical documentation for medical devices. The sampling plan, rooted in device classification and representative sampling, helps ensure compliance with rigorous standards. The evaluation criteria include aspects such as device usage, biocompatibility, clinical and performance aspects, risk management, sterilization validation, and design conformity. Exceptional scenarios permit deviations under specific circumstances, subject to detailed justification and evaluation by NBs. Adherence to these processes is paramount, as they ensure device safety and efficacy, instilling confidence in Regulatory authorities and the EU market consumers. Would you like to know more about the sampling of devices and technical documentation assessment by NBs? Reach out to us now!
