Medical Device MHRA Compliance – How to Ensure Regulatory Standards for the UK Market?
The Medicines and Healthcare products Regulatory Agency (MHRA) is a UK executive agency under the Department of Health and Social Care. Its main role is to ensure effectiveness and safety of medicines and medical devices in the region.
Established in 2003, the MHRA was previously part of the European system of approval. As part of this system, the MHRA, along with other national bodies, played a significant role in verifying pharmaceutical applications on behalf of all members. However, after the UK’s departure from the European Union in January 2021, the MHRA became an independent organization.
Eclevar Medtech, as an experienced and renowned Contract Research Organization, has the expertise to offer quality services and solutions for market approval in the UK. Keep reading to understand the recent changes in Medical Device MHRA Compliance and how we can help you navigate through the regulatory process.
The role of MHRA
The MHRA is divided into three main centres:
- MHRA Regulatory
- Clinical Practice Research Datalink
- National Institute for Biological Standards and Control
Besides that, MHRA has a great number of independent advisory committees that has the purpose to provide UK Government with guidance on the regulation of medicines and medical devices.
The Agency is responsible for the following activities:
- Operating post-marketing surveillance
- Assessing and authorise medicinal products for supply and sale in the UK.
- Reviewing Notified Bodies that ensure medical device manufacturers comply with regulatory requirements
- Performing quality surveillances systems that sample and test medicines
- Investigating online sales and potential forging of medicines, taking action when necessary
- Regulating clinical trials for medicines and medical devices.
- Monitoring the compliance with statutory obligations relating to medicines and medical devices.
- Promoting safe use of medicines and devices.
- Managing the Clinical Practice Research Datalink and the British Pharmacopoeia.
Medical Device MHRA Compliance – Applicable regulations for market in the UK
The Medicines and Healthcare products Regulatory Agency (MHRA) serves as the designated authority responsible for administering and enforcing medical device laws in the United Kingdom. Their primary goal is to ensure the safety and quality of these devices, and they possess a range of investigatory and enforcement powers to fulfil this role.
For UK-based manufacturers planning to supply medical devices within the country, it is crucial to be familiar with the applicable regulations. These include:
the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002),
and the General Product Safety Regulations 2005 (SI 2005 No 1803).
Both of these regulations fall under the Consumer Protection Act 1987, making them safety regulations that the MHRA can investigate under the purview of the Consumer Rights Act 2015.
Recent changes in regulatory legislation
Since January 1, 2021, several changes have been implemented through secondary legislation to regulate the placement of medical devices on the market in Great Britain (England, Wales and Scotland):
- Manufacturers seeking to place medical devices on the Great Britain market now have a new pathway known as the UKCA marking. This product marking option allows for the lawful introduction of medical devices into the region.
- All types of medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices, and systems or procedure packs, must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being made available.
- Manufacturers based outside the Great Britain must name a UK Responsible Person to deal with specific tasks such as device registration.
- In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD), can continue to be placed on UK market until either their certificate expires or until June 30, 2030.
CE under MHRA Compliance for market placement in the UK
As of now, medical devices with a valid CE marking can be introduced into the Great Britain market until June 30, 2023. A valid CE marking indicates compliance with the necessary requirements for placing the medical device on the European Union (EU) market. However, pending approval from Parliament, MHRA intends to establish new timelines for the placement of CE marked medical devices on the Great Britain market.
General medical devices that adhere to the EU medical devices directive (EU MDD) or the EU active implantable medical devices directive (AIMDD) and possess a valid declaration and CE marking, will be eligible for placement on the Great Britain market until either the certificate expires or June 30, 2028, whichever occurs sooner.
These measures are being implemented to ensure a smooth transition and ongoing availability of CE marked medical devices in the Great Britain market while aligning with regulatory changes and requirements.
Eclevar – CRO Support for Medical Device MHRA Compliance
Eclevar UK are an active member of the Association of British HealthTech Industries (ABHI) and the British In Vitro Diagnostic Association (BIVDA). We work alongside their regulatory groups to support the ongoing work on the new regulations, and ensure we are aware of key updates on the progress.
Our comprehensive CRO support provides the Medical Device MHRA Compliance expertise you need to develop a customized approach that meets your needs and to ensure that your approval application reach regulatory requirements. Contact us to follow up with partnership.
