The European Commission gives clarity on borderline cases

By Annette van Raamsdonk

The European Commission (EC) Medical Device Coordination Group (MDCG) on borderline and classification issues has added some new cases to the Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5 (the manual). Despite the fact that several new cases have been added to the manual, it stays quite succinct compared to the good old “Manual on borderline and classification in the community regulatory framework for medical devices” which can still be used in parallel for certain devices.

Below we have summarized the new cases that have been added to the manual.

Device used intended to administer a medicinal product (drug device combination)

The packaging for a medicinal product is also intended for administering the medicine within a body orifice. Each package is one dose. The package is a single-dose mini tube, with a long nozzle, and is intended to administer the medicine. As such, this packaging has a medical intended use, and it is covered by the definition of a medical device article 2 (1) MDR.

Because the packaging and the medicine form a single integral product, which is actively intended for use in the given combination, and it is not reusable, the integral product is governed by Directive 2001/83/EC or Regulation (EC) No 726/2004. In that case, the relevant general safety and performance requirements (GSPR) set out in Annex I MDR apply as far as the safety and performance of the device part of the single integral product are concerned, and article 117 MDR applies.

Penis holster (Rule I)

The device is intended to be used for men who are incontinent or unable to go to the toilet. The device is placed at the tip of the glans and is partially covered by the foreskin. It can remain in place up till a maximum of 24 hours. 

The question raised, was whether the device is considered invasive, given its anatomical position (under the mucous membrane and on the glans). The MDCG borderline group decided this device is not considered invasive through a body orifice and therefore should be classified as a class I device according to Rule 1.

Syringe containing glass beads (Rule 3)

“The intended purpose of the syringe containing glass beads is the aseptic collection via a wing needle (venous collection), transportation, incubation for prolonged coagulation and separation of small amounts of blood for obtaining autologous conditioned serum (ACS) with an increased concentration of growth factors and IL-1Ra. Following a centrifugation step, the ACS (without glass beads) is transferred to another syringe and stored at appropriate temperature until local injection into the same patient.”

The manufacturer claims that the (uncoated) glass beads increase the surface area to support the effectiveness of the product and that the glass beads upon contact with polar surfaces accelerate coagulation of the collected blood. 

The syringe and blood collection tubes containing glass beads are non-invasive, but are intended to modify the blood composition, to administer it again to the patient. Since the chemical composition of the blood is modified other than by simple filtration/centrifugation or exchange of gas or heat, the device is classified as a class IIb device, according to Rule 3 first paragraph.

Endodontic needles for root canal irrigation (Rule 6)

The intended use of these flexible single-use needles is to irrigate the root canal, before endodontic treatment. Before this can be done, an opening is made in the crown of the tooth, removing organic and mineral debris and disinfecting the pulp chamber and root canals with an antiseptic solution. The needle penetrates through this surgical opening in the tooth, is connected to a syringe which contains the irrigation solution.

While some manufacturers might place the device on the market as a class I device according to Rule 5, because they are of the opinion irrigation to clean and disinfect the root canal is not a surgically invasive procedure, the EC argued differently. These devices penetrate through an artificial opening in the tooth, made by a surgical intervention, and as such these devices are class IIa device according to Rule 6.

Saline solutions for nasal irrigation (Rule 21)

This has been a borderline case for years. Again some manufacturers have placed these devices on the market as class I according to Rule 5. The device is a saline solution for nasal irrigation that is intended to relieve nasal congestion in infants, children and adults. There are many variants of these devices (sterile, non-sterile, single use, etc.), but generally taken, the saline solution consists of 0.9% (w/w) of sodium chloride (NaCl) dissolved in purified water.  The device is a substance-based device and is used in the nasal cavity.

Since the saline solution is applied in the nasal cavity and it achieves its intended purpose in this cavity, this device should be classified as a class IIa device according to Rule 21, in line with MDCG 2021-24 Guidance on classification of medical devices.

Conclusion 

The EC, Competent Authorities (CAs), Notified Bodies (NBs) and stakeholders clearly wanted to bring an end to some common classification disputes. These cases have followed the so called “Helsinki Procedure”, and while the outcome of the procedures is captured in the manual, it is not law. It is the outcome of a vote and discussion that took place between the EC, CAs and NBs and others, and therefore the manual should be considered  an authoritative document.

If you are a manufacturer of one of these devices and have placed the devices on the market as class I self-certified, the classification of your devices need to be reassessed.   We would expect these manufacturers to reassess the classification as well as compliance to the MDR before placing any of these devices on the market. If you are a manufacturer outside the European Union, discuss this with  your European Authorized Representative (such as Emergo Europe), who can further assist you.