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Alternate Paths to CE Marking and Regional Approvals

A CE marking for a medical device or medicinal product can open the door to the European Economic Area (EEA), a marketplace of 500 million consumers in 27 European Union member states as well as Iceland, Liechtenstein, and Norway. While the benefits of CE marking are certainly compelling, there can be significant challenges in completing the steps required to obtain it, especially for smaller companies. But what if there were an alternative path to certification? 

Smaller companies often lack the dedicated resources (such as a formal regulatory department) that can assist with the enormous amount of documentation that may be required for a CE marking. Additionally, the costs of engaging the services of a notified body and the time burden on staff to support conformity assessment can be daunting – so much so that many companies put off CE marking and fail to reap the benefits it can provide. 

Mutual recognition agreements (MRAs) 

One possible path to ultimately obtain CE marking (and potentially enter other new markets in the process) is to begin the compliance assessment process in a region with a mutual recognition agreement (MRA) in place with the EU. These mutual recognition agreements are made between trading partners to reduce technical barriers, such as duplication of product safety testing. The EU itself can be said to constitute one large MRA between its member states. MRAs are generally created in two different forms – traditional and enhanced.  

Traditional MRAs  

Traditional MRAs provide mutual recognition for conformity assessments (product safety testing) between regions. The signatories to the MRA have agreed that a designated conformity assessment body (CAB) can perform testing using the technical requirements of a signatory country and, following successful completion, the product can then be imported to all other signatory countries or regions with minimal or no retesting. One critical outcome from these agreements is that signatories do not have to “harmonize” or recognize each other’s requirements as being equivalent. They only require recognition of the competence of the designated CABs to conduct conformance testing, thus streamlining and removing barriers to trade. 

Enhanced MRAs 

Enhanced MRAs go further by recognizing the actual technical requirements and rules of the other signatories as being automatically equivalent. In all cases, enhanced MRAs are reliant on broad regulatory alignment between the signatories. While differing in scope, MRAs allow EU competent authorities and their counterparts to rely on signatory GMP inspections, share inspection and defect data, and bypass batch testing of many products prior to importation. 

International agreements  

The EU currently maintains MRAs for medicinal and/or medical device products with Australia, Israel, Switzerland, Japan, New Zealand, and the United States. The EU has also transitioned from an MRA to a comprehensive economic and trade agreement (CETA) with Canada that allows for similar reciprocal recognition of CABs and GMP practices for medicinal products. It should be noted that the United States Food and Drug Administration also currently supports MRAs with the EU and the United Kingdom for medicinal products. This may be of benefit to companies that have obtained approval to market in those regions and would like to expand into the United States. 

An alternative way forward 

Having confirmed that these mutual recognition agreements are still active and in place, it may be beneficial to companies with restricted resources to start their compliance assessment path in a smaller and possibly more cost-effective region such as Australia, using a regional notified body. The Australian Therapeutic Goods Administration (TGA) requires a “sponsor,” which is a role the chosen notified body should be authorized to fulfill. Depending on the product(s), taking this path could allow compliance testing and the creation of required documentation along with a more streamlined gap assessment before taking on the expense and expanded effort of moving into larger regions. These outputs should then be readily transferable to the EU for CE marking or to other regions with MRAs as budgets increase and marketing pushes expand.  

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