MHRA Registration and Approved Bodies for SaMD

MHRA Registration

The Medicines and Healthcare products Regulatory Agency (MHRA) registration is a mandatory requirement for placing medical devices, including Software as a Medical Device (SaMD), on the UK market. This registration process serves as a crucial regulatory checkpoint that ensures all devices meet safety and performance standards before becoming available to healthcare providers and patients.

Registration Requirements

When registering a medical device with the MHRA, manufacturers must provide comprehensive information including:

• Complete manufacturer details
• Administrative contact information
• Valid conformity certificates
• Applicable regulatory framework references
• Device classification and detailed specifications
• Identity of the UK approved body that conducted the conformity assessment

Registration with the MHRA must occur before placing the device on the Great Britain market (England, Wales, and Scotland). This requirement applies to all classes of medical devices, though the level of scrutiny and documentation varies by risk classification.

Post-Registration Obligations

After successful registration, manufacturers must maintain:

• Active post-market surveillance systems
• Procedures for recording and evaluating incidents
• Systems for implementing corrective actions when necessary
• Reporting mechanisms for serious adverse events

All serious adverse events related to the device must be promptly reported to the MHRA through their established vigilance system. This continuous monitoring forms an essential part of the medical device vigilance system, ensuring ongoing safety and effectiveness.

Approved Bodies

Approved bodies (formerly known as notified bodies in the EU system) are organizations designated by the MHRA to assess medical devices’ conformity to UK Medical Device Regulations (UK MDR). These bodies play a critical role in the regulatory process by independently evaluating whether devices meet the required standards before receiving UKCA marking.

Role and Responsibilities

Approved bodies:

• Evaluate technical documentation
• Assess quality management systems
• Conduct conformity assessments according to the device classification
• Issue certification for UKCA marking when requirements are met
• Perform periodic audits and reassessments

Current UK Approved Bodies

As of 2023, the MHRA has designated four UK approved bodies authorized to conduct conformity assessments:

1. BSI Assurance UK Ltd
2. DEKRA Certification UK Ltd
3. SGS United Kingdom Ltd
4. UL International (UK) Ltd

Manufacturers can select any of these bodies for their conformity assessment, though some may specialize in specific types of devices or have particular areas of expertise.

Certification Pathways

The assessment pathway varies by device classification:

• Class I devices (non-sterile, non-measuring): Self-certification with minimal approved body involvement
• Class I sterile, Class I measuring, Class IIa, Class IIb, and Class III devices: Require full approved body assessment through various conformity routes

Transition from CE to UKCA Marking

Following Brexit, the UK has established the UKCA (UK Conformity Assessed) marking system. However, certain CE-marked devices are still accepted during the transition period:

• Class III devices with EU MDD certificates: Until December 31, 2027
• Class I, IIa, and IIb devices with EU MDD certificates: Until June 30, 2028
• All devices with EU MDR certificates: Until June 30, 2030

After these dates, all medical devices will require UKCA marking to be legally placed on the UK market.

Practical Implications for SaMD Developers

For developers of Software as a Medical Device:

1. Determine classification first: Proper classification determines the registration pathway and level of approved body involvement required (try our classification tool)
2. Select an appropriate approved body: Consider their experience with software and digital health technologies
3. Prepare comprehensive technical documentation: Include software validation, verification, and risk management information
4. Plan for ongoing surveillance: Establish systems for monitoring performance and safety after market placement
5. Stay informed about regulatory changes: The UK regulatory framework continues to evolve post-Brexit

References

1. Medicines and Healthcare products Regulatory Agency. (2023). Medical devices: How to comply with the legal requirements. https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements
2. National Institute for Health and Care Research. (2023). Software as a Medical Device (SaMD) Regulatory Pathway. NIHR HealthTech Research Centre in Devices, Digital and Robotics.
3. Medicines and Healthcare products Regulatory Agency. (2023). Register medical devices to place on the Great Britain market. https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-great-britain-market
4. Medicines and Healthcare products Regulatory Agency. (2022). Implementation of the future regulations for medical devices and extension of standstill period. https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period
5. Medicines and Healthcare products Regulatory Agency. (2023). UK approved bodies for medical devices. https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies

For the most current information on MHRA registration and UK approved bodies, visit the MHRA website or contact them directly for specific guidance related to your medical device.