Regulatory Open Forum

Hi all,

I have a syringe (no attached needle, no graduation markings, not sterile) that I am classifying under EU MDR and wanted to get other people's thoughts. 

The syringe contains diluent but is used to reconstitute a drug and administer via co-packaged needle. 

Under MDR, I think the syringe would be considered a non-invasive device as it's not penetrating the body through a body orifice/surface and therefore can be considered Class I under rule 2. The MDCG guidance, however, calls out rule 6 for syringes but I think that may be referring to syringes with pre-attached needles. What are other people's thoughts on this?

Thank you!

This is a good question as such a situation (physically separate diluent syringe) is not explicitly covered in effective MDCG Guidance on classification/borderline products or in the medicinal product directive (2001/83).<o:p></o:p>

From what I understand, though, such diluent syringes are considered part of the medicinal product and are not 'standalone' medical devices in this scenario. They would be evaluated as a part of the medicinal product submission (MAA) and would not be CE marked. However, due to MDR Article 117, these would be considered 'single integral' combination products and would require a NBOp (as pre-filled syringes fall under that category per EMA guidance).<o:p></o:p>

An example I'm aware of is Alprolix (eftrenonacog alfa) which was approved prior to implementation of MDR (so, it did not require a NBOp), however the diluent syringe ('solvent') is clearly reviewed as a part of the medicinal product - see Section 2.2.4 of the EPAR, starting on page 16.
<o:p></o:p>

Feel free to reach out directly if you'd like to discuss further!

Hi all,

I have a syringe (no attached needle, no graduation markings, not sterile) that I am classifying under EU MDR and wanted to get other people's thoughts. 

The syringe contains diluent but is used to reconstitute a drug and administer via co-packaged needle. 

Under MDR, I think the syringe would be considered a non-invasive device as it's not penetrating the body through a body orifice/surface and therefore can be considered Class I under rule 2. The MDCG guidance, however, calls out rule 6 for syringes but I think that may be referring to syringes with pre-attached needles. What are other people's thoughts on this?

Thank you!

after reading the 1^st mail, my understanding is, that the concerned syringe containing the diluent of the medicine is part of the finished pharmaceutical product, therefore for the approval of the Marketing Authorisation of the medicine, the syringe in the EU needs to be either CE-marked or positively assessed by a Notified Body, as it was explained by Jonathan in the 2^nd mail.

The concerned regulations of its final assessment are the MDR and  Directive 2001/83/EC and its national applications.

Before used in the manufacturing procedure of the medicine, the syringe certainly gets sterilized, even if it is sold unsterile by the device manufacturer, as mentioned in the 1^st mail. So, the NB opinion will concern at least a sterile class I medical device.

regards

This is a good question as such a situation (physically separate diluent syringe) is not explicitly covered in effective MDCG Guidance on classification/borderline products or in the medicinal product directive (2001/83).<o:p></o:p>

From what I understand, though, such diluent syringes are considered part of the medicinal product and are not 'standalone' medical devices in this scenario. They would be evaluated as a part of the medicinal product submission (MAA) and would not be CE marked. However, due to MDR Article 117, these would be considered 'single integral' combination products and would require a NBOp (as pre-filled syringes fall under that category per EMA guidance).<o:p></o:p>

An example I'm aware of is Alprolix (eftrenonacog alfa) which was approved prior to implementation of MDR (so, it did not require a NBOp), however the diluent syringe ('solvent') is clearly reviewed as a part of the medicinal product - see Section 2.2.4 of the EPAR, starting on page 16.
<o:p></o:p>

Feel free to reach out directly if you'd like to discuss further!

Hi all,

I have a syringe (no attached needle, no graduation markings, not sterile) that I am classifying under EU MDR and wanted to get other people's thoughts. 

The syringe contains diluent but is used to reconstitute a drug and administer via co-packaged needle. 

Under MDR, I think the syringe would be considered a non-invasive device as it's not penetrating the body through a body orifice/surface and therefore can be considered Class I under rule 2. The MDCG guidance, however, calls out rule 6 for syringes but I think that may be referring to syringes with pre-attached needles. What are other people's thoughts on this?

Thank you!

after reading the 1^st mail, my understanding is, that the concerned syringe containing the diluent of the medicine is part of the finished pharmaceutical product, therefore for the approval of the Marketing Authorisation of the medicine, the syringe in the EU needs to be either CE-marked or positively assessed by a Notified Body, as it was explained by Jonathan in the 2^nd mail.

The concerned regulations of its final assessment are the MDR and  Directive 2001/83/EC and its national applications.

Before used in the manufacturing procedure of the medicine, the syringe certainly gets sterilized, even if it is sold unsterile by the device manufacturer, as mentioned in the 1^st mail. So, the NB opinion will concern at least a sterile class I medical device.

regards

This is a good question as such a situation (physically separate diluent syringe) is not explicitly covered in effective MDCG Guidance on classification/borderline products or in the medicinal product directive (2001/83).<o:p></o:p>

From what I understand, though, such diluent syringes are considered part of the medicinal product and are not 'standalone' medical devices in this scenario. They would be evaluated as a part of the medicinal product submission (MAA) and would not be CE marked. However, due to MDR Article 117, these would be considered 'single integral' combination products and would require a NBOp (as pre-filled syringes fall under that category per EMA guidance).<o:p></o:p>

An example I'm aware of is Alprolix (eftrenonacog alfa) which was approved prior to implementation of MDR (so, it did not require a NBOp), however the diluent syringe ('solvent') is clearly reviewed as a part of the medicinal product - see Section 2.2.4 of the EPAR, starting on page 16.
<o:p></o:p>

Feel free to reach out directly if you'd like to discuss further!

Hi all,

I have a syringe (no attached needle, no graduation markings, not sterile) that I am classifying under EU MDR and wanted to get other people's thoughts. 

The syringe contains diluent but is used to reconstitute a drug and administer via co-packaged needle. 

Under MDR, I think the syringe would be considered a non-invasive device as it's not penetrating the body through a body orifice/surface and therefore can be considered Class I under rule 2. The MDCG guidance, however, calls out rule 6 for syringes but I think that may be referring to syringes with pre-attached needles. What are other people's thoughts on this?

Thank you!