Objective:

The article reports New World Medical’s EU MDR certification for the Ahmed Glaucoma Valve, Ahmed ClearPath, and KDB GLIDE, and its ongoing effort to obtain certification for the Ahmed ClearPath ST.

Approach:

• Certification: New World Medical announced that the Ahmed Glaucoma Valve (AGV), Ahmed ClearPath (ACP), and KDB GLIDE received EU Medical Device Regulation certification.
• Device roles: AGV and ACP are glaucoma drainage devices; KDB GLIDE is a surgical instrument used to perform excisional goniotomy.
• Next objective: New World Medical is pursuing EU MDR certification for the Ahmed ClearPath ST (ACP ST), with discussions ongoing with its notified body.

Key Findings:

• The three certified devices were previously available in Europe under the Medical Device Directive.
• The company says MDR certification allows it to continue supplying the devices to surgeons across Europe.
• ACP ST is approved in more than 20 countries but has not received EU MDR certification.

Interpretation:

The company says MDR certification allows it to continue supplying AGV, ACP, and KDB GLIDE to surgeons in Europe. It is also pursuing EU MDR certification for ACP ST, which is approved in more than 20 countries but has not yet received EU MDR certification.

Limitations:

• The source does not state a timeline for ACP ST certification.

Conclusion:

New World Medical reports EU MDR certification for AGV, ACP, and KDB GLIDE and says discussions are ongoing with its notified body regarding certification of ACP ST.

Sources:

• New World Medical announcement, as summarized in the provided context