MHRA Requirements for the Storage of Radioisotopes: Navigate the Minefield
Do you know what the MHRA requires of your radioisotope vial?
If you work in a US facility preparing radiopharmaceutical doses for patient administration, then you are likely filling these doses into an internally sterile nitrogen-filled vial. You may or may not be aware that this vial is officially a medical device, and as such must adhere to certain regulations for it to be used safely and legally.
This article aims to assist you in understanding what the MHRA mandates as necessary for medical devices and how you can ensure the vials you are using meet these requirements.
Use our Free Supplier Evaluation Checklist to ensure your vials meet MHRA requirements.
When is a sterile vial a medical device?
A medical device is any instrument (other than a drug) that is used to diagnose, monitor, treat, or manage a medical condition (as defined by MDD Article 1.2a, MDR Article 2.1, UK MDR Part I Interpretations). Radiopharmacies use sterile nitrogen-filled vials to hold doses of radioisotopes which are used for diagnosing and treating diseases such as cancer and kidney disease, and this is why they are deemed medical devices.
It is important to be aware that where a sterile vial is being sold as a medical device in the UK it must meet strict requirements and be registered with the relevant authorities. Historically this has meant complying with the EU MDD and having a CE Mark. Following Brexit, oversight of medical devices is transitioning to UK rule and will be covered by the UK MDR, and by 2030 all medical devices sold in the UK will need to be fully transitioned to the UK MDR and bear the new UKCA Mark.
Radiopharmacies and nuclear medicine departments using sealed vials for patient doses should ensure these containers meet the necessary requirements. In this article we explain what you need to look out for to ensure you’re compliant with UK law and are best protecting your patients.
Should my medical device have a CE or a UKCA mark?
Medical devices are required to bear relevant marking. During the transition from EU MDD to UK MDR, there are actually three conformity assessment routes which can be applied to medical devices to obtain either a UKCA or CE mark.
Here’s what you need to check depending on which mark your vial displays.
UKCA Marking – UK MDR
What you need:
- Evidence of MHRA registration for the manufacturer and product (including details of UK responsible person if the manufacturer is not UK based)
- UKCA certification with a scope covering the purchased product
- UK Declaration of conformity detailing the part number of the product
CE Marking – MDR
What you need:
- Evidence of MHRA registration for the manufacturer and product (including details of UK responsible person if the manufacturer is not UK based)
- CE certification in accordance with MDR with a scope covering the purchased product
- EU Declaration of conformity detailing the part number of the product
- Confirmation of EUDAMED registration showing appointed EU Authorized Representative and valid Mandate
CE Marking – MDD
What you need:
- Evidence of MHRA registration for the manufacturer and product (including details of UK responsible person if the manufacturer is not UK based)
- CE certification in accordance with MDD with a scope covering the purchased product, plus, a notified body letter declaring they have an extension to the certificate in line with Article 120 of the MDR.
- EU Declaration of conformity detailing the part number of the product
- Confirmation of EUDAMED registration showing appointed EU Authorized Representative and valid Mandate
UK vs Non-UK Manufacturers
The MHRA will only accept registration of devices from manufacturers where the legal manufacturer is based in the UK. Non-UK based manufacturers must appoint a UK responsible person. This UK responsible person will then assume responsibilities on behalf of the manufacturer including registering the device with the MHRA. Here’s what you need to know:
Scenario 1: Your vial manufacturer is UK based
If the legal manufacturer of your sterile nitrogen-filled vial is based in the UK, you should ensure they can demonstrate that they:
- Are registered with the MHRA
- Have a notified body
- Have a valid up-to-date Declaration of Conformity stating a GMDN code that is applicable to your use of the product.
- Hold UKCA (UK Conformity Assessed) certification (or CE certification in accordance with the transition provisions)
Scenario 2: Your vial manufacturer is based outside of the UK
If the legal manufacturer of the vials is based outside of the UK, they should have everything a compliant UK manufacturer will have (see above), plus the following:
- An appointed UK Responsible Person, who will assume certain responsibilities on behalf of the manufacturer including registering the device with the MHRA
- Written evidence from the UK responsible person that they have the manufacturer’s authority to act as such
- The name and address of the UK responsible person must be included either:
- On the product labeling or outer packaging
- Or on the ‘Instructions for Use’ in cases where UKCA marking has been achieved
- A UK-based importer to control the release of goods into the UK
If the device is being placed on the market under CE certification the manufacturer must also:
- Be registered in EUDAMED as an economic operator.
When will CE marking cease in the UK?
The guidance in this article refers to the transitional period from EU to UK regulation. CE marking will no longer be recognized in the UK after June 30, 2028 (CE MDD) or June 30, 2030 (CE MDR) depending on the type of CE certificate held. After this point all medical devices sold into the UK must have a valid UKCA mark in accordance with the UK Medical Device Regulations.
We are pleased to confirm our Anoxos® sterile nitrogen-filled vials comply with all UK MDR requirements and hold both CE and UKCA marks. You can access our CE (MDD), CE (MDR) and UKCA certificates on our website.
Need help navigating the minefield?
We appreciate this is a complex topic to navigate, and we’re here to support you should you need help understanding what is and isn’t compliant with MHRA requirements.
Please contact our expert team for advice: sales@adelphi-hp.com
For more information on the regulations surrounding medical devices being used in the UK, visit: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#legislation-that-applies-in-great-britain
Supplier Evaluation Checklist
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