This month, Eleanor and Emily Pittard discuss why MHRA registration is crucial as a dental lab, and provide a step-by-step guide to a simple process.
In the realm of healthcare, precision and safety are paramount, especially in dentistry where custom-made devices and materials play a pivotal role in patient care.
For dental laboratories and dental clinics, registering with the Medicines and Healthcare products Regulatory Agency (MHRA) is not just a procedural checkbox; it’s a critical step toward compliance, ensuring high standards of quality and safety.
Understanding MHRA registration
The MHRA serves as the UK’s regulatory body responsible for ensuring the safety, quality, and effectiveness of medical devices and materials used in healthcare. Dental laboratories and clinics engaging in the manufacture, modification, or distribution of custom-made dental devices fall under the purview of MHRA regulations.
This is something that is well-known to dental laboratory owners, but for those of you just about to enter the field of owning a laboratory it might not be something you have come across before. It is also important to note that if you own a dental clinic that offers things like Cerec for same-day crowns or prints aligners in house, then you must also register with the MHRA to stay legally compliant.
Why Register with MHRA?
Legal compliance: Registration with the MHRA is a legal requirement for anyone producing custom-made medical devices. Failure to comply can result in legal repercussions, including fines and limitations on conducting business.
Quality assurance: MHRA registration ensures adherence to stringent quality standards, promoting patient safety. It mandates compliance with governing materials, manufacturing processes, and quality management systems, ensuring consistent and safe products for patients.
Traceability and accountability: Registration involves maintaining comprehensive records of materials, production processes, and distribution channels. This facilitates traceability, enabling rapid response in case of recalls or quality issues, ultimately safeguarding patients and practitioners.
Enhanced reputation: MHRA registration signals a commitment to quality and safety, enhancing the credibility and reputation of the dental laboratory or clinic. It instills trust among dental professionals and patients, showcasing a dedication to providing reliable and safe dental appliances.
Steps to register with MHRA as a dental laboratory
Determine eligibility: Identify if you fall under the definition of a manufacturer or distributor of custom-made medical devices according to MHRA guidelines.
Gather necessary information: Collect detailed information about your laboratory or clinic, including manufacturing processes, materials used, quality management systems, and distribution channels.
Complete application: Access the MHRA online portal and fill out the necessary forms for registration. Provide accurate and comprehensive information to expedite the process.
Submit supporting documents: Along with the application, submit supporting documents such as quality management system documentation, material specifications, and details of manufacturing processes.
Comply with ongoing requirements: Maintain compliance with MHRA regulations by adhering to quality standards, updating records, and promptly reporting any incidents or changes that may affect product safety or quality.
Conclusion
We are all painfully aware of how much regulation and compliance we have to undertake in the dental industry, and it can be a bit overwhelming at first.
The best thing to do is to designate someone in your lab or practice roughly one day to read through and put everything together to register with the MHRA. Then it becomes part of their responsibility to check for updates and make sure everything remains complaint.
Not only is it a legal requirement, but it is a commitment to ensuring the highest standards of quality, safety, and accountability in the production of custom-made dental devices.
It’s a fundamental step towards ensuring patient safety and maintaining quality standards.
Catch up with the previous Technically Speaking columns:
- A guide to safeguarding in a dental laboratory
- How to navigate the UK dental market
- What the lab industry can learn from clinics – and vice versa
- Why Pride Month is for everyone
- Recruitment and utilising the existing team.
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