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Plan and Transition with Confidence
The In-Vitro Medical Diagnostic Regulation (IVDR) is the latest in a series of regulatory revisions from the European Union (EU) regarding safety and quality standards for medical devices, including diagnostic assays. This EU regulation enters into force in May 2022, leaving limited time for manufacturers to ensure product compliance and retain access to the European market.
What’s more, several countries outside the European Union, especially in Asia, are also implementing similar regulatory programs on similar timelines, making IVDR compliance also important for manufacturers outside the European market. New regulations can be daunting, especially on the limited timeline remaining for IVDR compliance, so here are a few ways to navigate the process of making sure one’s products are IVDR-compliant.
1. What Is Your Product’s IVDR Classification?
One of the changes the IVDR represents over its predecessor, the In Vitro Medical Devices Directive (IVDD), is a new set of product classifications. Products can fall into categories A, B, C, or D, each with their own definitions, and the criteria that mark a product as belonging to one category or another can be tricky to parse.
Get more information: IVDD vs. IVDR: Classifications Defined and Compared – IVDR classifications and what determines them.
2. What Is Your Product’s Commercial Status?
The path to IVDR compliance might look very different depending on how close to commercialization your product already is.
If your product is already on the market under the IVDD, look for differences in regulatory requirements between the two laws. For example, the IVDR has a clarified and expanded definition of an in vitro diagnostic test compared to its predecessor, which may change the category encompassing a particular product. Also, far more products will require regulatory oversight under the IVDR.
Among the challenges imposed by the new regulations on existing products is that the IVDR requires manufacturers to have a certified quality management system. Many companies are not ready to support this requirement, and therefore need to partner with another entity in order to continue selling into the EU. A company like Thermo Fisher Scientific can support assay developers by providing relevant documents, including provisions, contracts, and certifications to support developers with their quality management system and IVDR compliance.
Existing products may also require changes to their supply pipeline to comply with the IVDR, in particular to establish a manufacturing process using higher-quality raw materials. Products may also need additional validation studies that show that their performance meets the new, higher standards. Thermo Fisher Scientific offers a variety of materials that can be used to improve IVDR compliance as well as consultative services for these new validation efforts.
When developing new products, it is possible for manufacturers to do so with the IVDR in mind. That means familiarizing yourself with what the IVDR entails for both product categories and the compliance process. All in-vitro diagnostic products manufactured with a CE mark will be affected, so having a look at the resources Thermo Fisher Scientific offers for IVDR compliance will be a good place to start.
3. What’s Your Next Move?
Establishing compliance with a new regulatory regime is no small task. Depending on the gaps you have identified, the question becomes: do you address them in-house, or do you bring in outside assistance? Working with an OEM partner whose technology is already IVDR-compliant can mean having one less thing to worry about and having a swift, relatively simple path toward assuring the compliance of one’s products. Thermo Fisher Scientific’s IVD instrument products will primarily be Class A under IVDR regulation and will be self-certified when the IVDR enters force in May 2022, and the OEM team stands ready and willing to assist assay manufacturers with establishing IVDR compliance for their products.
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