MHRA (UK) UKCA Certification Testing for Medical Devices
Ensuring compliance with the Medical Device Regulations (MDR), 2017/745/EU, is a crucial aspect of delivering safe and effective medical devices to the market. The Medicines and Healthcare products Regulatory Agency (MHRA) oversees this process in the UK, providing certification through the United Kingdom Conformity Assessed (UKCA) mark for medical devices that are intended to be sold or used within the UK.
The MHRA UKCA certification testing is a multi-step process designed to ensure that each device meets all relevant regulatory and technical requirements. The first step involves a comprehensive review of the product’s design, specifications, and documentation by the notified body. Following this initial assessment, specific tests are conducted in our state-of-the-art laboratory facilities.
The key factors influencing this testing include:
- Device classification
- Purpose and intended use of the device
- Materials used in the construction of the device
- Risk assessment as per ISO 14971
The MHRA UKCA mark is a symbol of trust for healthcare professionals, patients, and consumers. It assures them that the product has passed stringent testing standards to meet safety, quality, and performance requirements.
Our laboratory adheres strictly to internationally recognized standards such as ISO 13485:2016 and ISO 9001:2015 for quality management systems. We have extensive experience in conducting tests that align with the MHRA UKCA certification process, including:
- Biocompatibility testing
- Cytotoxicity assessment
- Allergenicity evaluation
- Immuno-genic potential analysis
- Aqueous extractable evaluation
- Release testing of chemicals
- Microbial contamination checks
- Bacterial endotoxin testing
In addition to these tests, we also perform performance evaluations such as:
- Biomechanical testing
- Mechanical stability assessment
- Electrical safety checks (if applicable)
- Environmental stress cracking resistance evaluation
- Heat aging tests
The detailed nature of the tests ensures that all potential risks and hazards are identified early, thus enabling manufacturers to address any issues before certification.
To provide further context, here is a summary of the applied standards:
| Standard Number | Title and Description |
|---|---|
| ISO 10993-1 | Biocompatibility evaluation of medical devices Part 1: Evaluation and testing procedures |
| EN ISO 14971 | Risk management for medical devices |
| ISO 80601-2-35 | Particular requirements for electrical equipment used in the measurement of blood glucose, HbAc, and cholesterol levels |
The MHRA UKCA certification process is designed to ensure that all medical devices are safe, effective, and reliable. By adhering strictly to these standards, our laboratory plays a vital role in the compliance journey of medical device manufacturers.
Applied Standards
| Standard Number | Title and Description |
|---|---|
| ISO 10993-1:2018 | Biocompatibility evaluation of medical devices Part 1: Evaluation and testing procedures. This standard covers the basic principles for assessing biocompatibility, including non-clinical tests. |
| EN ISO 14971:2019 | Risk management for medical devices. It provides a framework to help manage risks throughout the lifecycle of a product, ensuring safety and effectiveness. |
| ISO 80601-2-35:2017 | Particular requirements for electrical equipment used in the measurement of blood glucose, HbAc, and cholesterol levels. This standard ensures accuracy and reliability in these specific medical devices. |
The MHRA UKCA certification process is designed to ensure compliance with these standards, thereby ensuring that all medical devices are safe, effective, and reliable for use by healthcare professionals and patients.
Scope and Methodology
| Step | Description |
|---|---|
| Initial Assessment | The notified body reviews the documentation provided by the manufacturer to ensure compliance with the MDR and other relevant regulations. |
| Testing | Conducts a series of tests based on the device's classification, including biocompatibility, electrical safety (if applicable), and performance evaluations. These tests are conducted using our advanced equipment and facilities. |
| Risk Assessment | The notified body performs a comprehensive risk assessment according to ISO 14971:2019, ensuring that all potential risks are identified and mitigated. |
| Certification | If the device passes all tests and meets all acceptance criteria, it is granted the UKCA mark, allowing it to be legally sold in the UK market. |
The MHRA UKCA certification process is a rigorous one that ensures the safety and efficacy of medical devices. Our laboratory adheres strictly to these steps and uses leading-edge technology to ensure accurate and reliable testing results.
Customer Impact and Satisfaction
- Ensures compliance with MHRA UKCA certification standards
- Reduces time-to-market through streamlined testing processes
- Enhances product safety and reliability
- Improves customer trust in the efficacy of medical devices
- Facilitates easier access to the UK market for international manufacturers
- Provides peace of mind for healthcare professionals using the device
Our clients have consistently reported high levels of satisfaction with our services. We take pride in delivering accurate, reliable test results that meet or exceed regulatory expectations.
