April 13, 2021
As you are aware, the EU will soon be fully implementing the requirements of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Per our current CE Authorized Representative, full compliance with the documentation and administrative requirements is mandated to be 26 May 2021.
3M Press-On™ Optics:
As a distributor and supply chain entity of the 3M Press-On™ Optics products, The Fresnel Prism and Lens Company has worked to implement the necessary Quality management System (QMS) processes and procedures required to comply with the EU MDR requirements for the distribution of the 3M Press-On™ Optics to our customers in the EU and European Economic Area (EEA) nations.
3M has redesigned the Press-On™ Optics product packages and instructions insert to fully comply with the EU MDR requirements. This product redesign, package and insert only, required the assignment of new item numbers to reflect these necessary revisions. And as the manufacturer of the Press-On™ Optics products, 3M is responsible for documenting the item number changes in the EU Medical Device Master Data File per the MDR requirements.
All is in order with respect to the 3M Press-On™ Optics products so we are not anticipating any EU/EEA processing or delivery issues, deliveries should process as they always have.
Please note that the product item numbers which you have been using to order 3M Press-On™ Optics products are still valid and are preferred on orders rather than the new, lengthy item numbers assigned, those presented as the product’s UDI (01) numbers on the new packages.
In the event you require a complete listing of these new item numbers, please contact our office and we will provide a Press-On™ Optics Product Item Number Matrix for your reference.
Bangerter Occlusion Foils:
As a distributor and supply chain entity of the Bangerter Occlusion Foil products, The Fresnel Prism and Lens Company has updated our QMS to address the necessary processes and procedures required to comply with the EU MDR requirements for the distribution of the Bangerter Occlusion Foil products to our customers in the EU nations.
Ryser Ophthalmologie is the manufacturer of the Bangerter Occulsion Foil products. And as the manufacturer of the Bangerter Occlusion Foils, Ryser Ophthalmologie is updating the products, package and instructions, to satisfy the EU MDR requirements and are responsible for documenting the Bangerter Occlusion Foil products in the EU Medical Device Master Data File per the MDR requirements.
However, please understand that Ryser’s MDR compliance effort is still in-work at this time, but Ryser Ophthalmolgie is committed to satisfying the MDR requirements to ensure the availability of these products to the patients who require them. We appreciate your patience should you experience a delay regarding the availability of these products.
Other Products:
MYI and CoverClude Eye Patches, Temporary Eye Patch Rolls, Fresnel Prism Trial Sets, Bangerter Foil Bars, and other products offered
We regret that we must advise you that The Fresnel Prism and Lens Company will NOT be registering our MYI or CoverClude Eye Patch products, Temporary Eye Patch product, Fresnel Prism Trial Sets, Bangerter Foil Bars, nor any of the other unnamed products that we presently offer and provide to our EU customers into the EU Medical Device Master Data File. Medical device products MUST be registered as medical devices in the EU Medical Device Master Data File in order to import them after the full MDR implementation date.
What does this mean to you?
These Other Products will no longer be eligible for EU or EEA import after full implementation of the EU MDR on 26 May 2021.
These Other Products are still available for purchase and import into EU and EEA nations up to the 26 May 2021 MDR full implementation date.
It is our understanding that all product imported prior to the 26 May 2021, full implementation date may still be sold within the EU and EEA until the inventory has been depleted.
We understand that these Other Products are very useful in helping you, or your customers, help the patients, but it is not a good business decision for our company to continue to pursue EU/EEA sales of these Other Products.
The Basis of our reasoning for this difficult decision was simple: Cost. The total of the costs required to establish and then maintain EU MDR compliance for these Other Products far exceeded the net return realized on the sales. Unlike 3M, a very large international corporation with offices within various EU nations, our company is a very small business. Compliance with the EU MDR requirements not only requires that our business comply with the processes and procedures aspects of the MDR, but our business must register each of our Other Products in the EU Medical Device Master Data File (an expensive requirement for each individual product) and, our present CE Authorized Representative has informed us that our company must also establish and maintain an office located in the EU along with an EU bank account to support EU related regulation needs, EU office expenses, and sales transactions. Again, the sum of the EU MDR financial requirements has rendered this aspect of our business to be non-viable in the EU.
We are sorry for the inconvenience of our decision, but we look forward to helping you satisfy your products needs as you prepare for full MDR implementation.