Changes are changes, are they not? Brexit being a reality, it can now be presumed that the UK regulatory regime will end up differing from the EU one, thus the industry shall be well-informed and duly advised. Heads up! First differences are already peering out the window.
Although the exit of the UK from the EU is still a hard topic for its recentness – and no feverous changes have yet taken place regarding regulatory requirements, other than appointing an UK RP and proceed with the appropriate registrations, of course – we start to notice differences in the essence of prohibitions and allowances: The MHRA allows DEHP phthalates in medical devices.
What are Phthalates and in which medical devices are they most commonly present?
Phthalates are chemicals added to polyvinyl chloride (PVC) plastic to make it softer and more flexible. Di (2-ethylhexyl) phthalate (DEHP) is the type used the most in medical devices such as:
- Intravenous (IV) tubing;
- Umbilical artery catheters;
- Blood bags and infusion tubing;
- Enteral nutrition feeding bags;
- Nasogastric tubes;
- Tubing used in cardiopulmonary bypass (CPB) procedures;
- Tubing used in extracorporeal membrane oxygenation (ECMO);
- Tubing used during hemodialysis;
- Tubing used during peritoneal dialysis.
It is well known by the industry that DEHP can make medical devices more flexible and, hence, prevent them from causing damage to human tissue. Besides, they become more comfortable for patients, as the materials thickness is smoothened. This is the main reason why phthalates are used in medical devices and even more often and with a wider variety of reasons in IVDs.
This leads us to the obvious question:
Is it safe to use medical devices with DEHP?
The UK Authority (MHRA), with due consideration to the Scientific Committee on Emerging and Newly-Identified Health Risk conclusion (SCENIHR 2015), is of the following opinion and recognises:
- The possibility of the DEHP leaching from the PVC into solutions like blood or nutrition formulas;
- Birth defects and infertility in animals with certain doses of the phthalate.
However, the MHRA contends there is no consistent evidence as to suggest that medical devices containing DEHP pose an unacceptable health risk to humans. Conversely, they are of the firm belief that medical devices containing PVC with DEHP have an important clinical benefit. Hence, when doing the benefit-risk balance, the use of the DEHP seems acceptable.
In this light, the MHRA’s position is that no additional regulatory measures are necessary when phasing out the use of DEHP in medical devices. The Medical Device Regulations (SI 2002 No 618, as amended) (UK MDR 2002) require any materials presenting a hazard to be replaced as soon as alternatives with a more positive risk-to-benefit balance are available. However, those are not there yet. It appears that DEHP may still be essential in some medical devices in critical circumstances.
We can conclude that the MHRA encourages the searching for alternatives to the use of DEHP, but does not condemn its use. Seizing the opportunity, we stress that the use of DEHP by manufacturers in the EU after the MDR needs to be justified soundly.
How to legally place your DEHP medical devices on the UK market?
Manufacturers shall follow the wording of the UK MDR 2002, as usual before placing medical devices on the market. The devices at stake can be either CE (until 30 June 2023), UKCA or CE UKNI marked; nevertheless, as you may already know, there are different requirements for the UK and Northern Ireland markets.
In the light of the foregoing, manufacturers need to be well aware of the fact that, in order to place their medical devices on the UK market, they will have to ensure that any risk, such as from exposure to DEHP, is outweighed by the anticipated benefits to the patient, with the goal of reducing the risk as far as possible .
Carlos Francisco Marín Barrios
Regulatory Affairs Department
Should you like to know if you can use the standard during the manufacturing of your masks, or if you simply wish to enter the UK market with your devices and need help with their classification, do not hesitate and contact our experts at Obelis.com.
Bibliography: GOV.UK. Medicines & Healthcare products Regulatory Agency. (2021). Guidance DEHP phthalates in medical devices. 26 January 2021. Retrieved on 02/06/2021 from https://www.gov.uk/government/publications/dehp-phthalates-in-medical-devices/dehp-phthalates-in-medical-devices
BSI., Preliminary Guidelines on Phthalates in Medical Devices. 23 April 2019. Retrieved on 02/06/2021 from: https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/preliminary-guidelines-on-phthalates-in-medical-devices/
GOV.UK., Medicines & Healthcare products Regulatory Agency; Guidance Using the UKCA marking. 1 june 2021. Retrieved on 02/06/2021 from: https://www.gov.uk/guidance/using-the-ukca-marking
SCENIHR., Opinion on The safety of medical devices containing DEHP-plasticized PVC or other plasticizers on neonates and other groups possibly at risk (2015 update). Retrieved on 02/06/2021 from: https://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_047.pdf