Selling Products Under Your CE Mark or Your Supplier’s – Top 5 Considerations
All medical device products sold in the EU need a CE mark. For the lowest-risk medical devices, it is possible to use a self-certification CE marking process. However, for class II and III medical devices, obtaining a CE mark is a much more complicated undertaking. So, should you do it yourself, selling medical device products with your CE mark? Or should you use your supplier’s CE mark?
The answer will depend on your circumstances, business model, and intentions. Here are the top five factors you should consider.
1. Device Modifications and the Product’s Brand Name
Requirements for CE marking differ depending on the category of your business. If you are an importer or distributor, for example, and you intend to sell the product under the OEM’s brand name, you can use the OEM’s CE mark. Importers and distributors must verify the product is properly CE marked and has a valid EU declaration of conformity, along with a range of other responsibilities. However, using the OEM’s CE mark is a viable option.
It is much more complicated if you plan to sell the product under your brand name. Furthermore, the level of complexity has increased with the introduction of the new Medical Device Regulation (MDR) in the EU.
Under the previous regulatory framework, own-brand labelers had to obtain their own CE mark certification, but they could do so using an abbreviated version of the OEM’s technical file.
MDR now requires own-brand labelers to have access to the OEM’s full technical documentation to obtain CE mark certification in addition to other requirements, such as keeping their own technical documentation and fulfilling post-market surveillance requirements.
Also, any modifications made to an OEM’s product or changes in the indications for use mean a new CE mark certification will need to be obtained.
2. Time to Market
The process of obtaining a CE mark for a product is complex and time-consuming. You first have to determine the intended purpose and classification of the product, as well as the conformity assessment route. You then need to take steps to ensure compliance with the conformity requirements, including putting in place a quality management system (QMS) and all the necessary technical documentation.
The product and all associated documentation must then go through an assessment by a Notified Body, and you need to sign a Declaration of Conformity. Once audited and approved by the Notified Body, you can obtain your CE marking certificate allowing you to place a CE mark on the product.
Remember also that having clearance from the FDA to sell your product in the US doesn’t mean the process to obtain a CE mark will be simple or straightforward. The EU’s MDR is not only complex, but has different requirements compared to, for example, the FDA’s 510(k) process for getting regulatory approval in the US.
Let’s look at an example using tearaway introducers to put the time-to-market issue in context. You could buy tearaway introducers in bulk from a supplier like Galt OEM with the intention of applying your own CE mark. However, even with our support, the EU approval process could take up to 18 months.
The alternative is to purchase sterile tearaway introducers that feature our CE mark, dramatically reducing your time to market.
Going through the CE mark certification process described in the above point is not only time-consuming, but also costly. There are also then additional costs to ensure ongoing compliance. By using your supplier’s CE mark, you remove the hassle and long timelines associated with CE mark certification, as well as reducing your costs.
4. MDR delays
MDR is the new set of regulations governing the sale of medical device products in the EU. As a result, MDR is crucial to obtaining a CE mark for the products you want to sell. The issue is the implementation of MDR has been hampered by problem after problem, leading to deadline extensions and general concern in the industry.
As a supplier of medical device products, your priority is getting a CE mark so you can start selling. As mentioned in an earlier point, if you start the process today, it could be a year and a half before you have the certification that you need. Using the CE mark from the product’s OEM could be the better option.
5. Availability of Regulatory Consultants
One of the key features of the new EU MDR is that it applies to legacy products as well as new products. This means all existing products have to go through the MDR approval process to get re-certified. This is one of the main reasons for the long delays in the MDR system.
One of the consequences of this feature of MDR is that regulatory consultants are now in high demand. In the previous point, we said it could take 18 months to obtain certification. That assumes you can find a regulatory consultant with availability to provide the support services you need. This is currently quite difficult.
Making the Right Choice for Your Situation
There are some situations where you can’t use a manufacturer’s CE mark, i.e., if you plan to modify the product and/or sell it under your brand name. If this applies to your business, you will have to go through the CE mark certification process.
If these situations are not applicable, you have alternative options – options that reduce time to market and costs, as well as the resources required to go through the process yourself. Using the product manufacturer’s CE mark is a viable alternative that often makes sound business, financial, and compliance sense.
At Galt OEM, we offer our products with a CE mark to save you the hassle, cost, and time of going through the certification process. Get in touch today to discuss your requirements.