Regulatory Open Forum

Your question involves two regulatory systems (US and EU) which are not comparable. They have very different requirements. The conventions in one do not carry over to the other.

In the US system a product is either a "full" IVDs or investigational. There are three categories of investigational: RUO, IUO, and Part 812.

In the US, there are Laboratory Developed Tests, LDTs, which are manufactured by commercial labs, run in the same lab, and used to deliver patient results. The US FDA exercises enforcement discretion, and does not regulate the manufacture of LDTs.

A lab should not purchase an RUO, claim it is an LDT, and use it to deliver patient results. FDA has told some companies that their devices do not qualify as an LDT and cited them in Warning Letters.

In the EU, the situation is very different. Consider the IVDR.

A product is either a device that satisfies all the requirements (and has a CE Mrk) or a product subject to a performance study.

The EU doesn't allow LDTs by commercial labs. Health institutions have an exception for their own use.

Can a company have a CE-IVD mark and still sell RUO versions in the EU lab?
No. In the EU, there are no RUO products. A product has either the CE Mark or is subject to a performance study. They are (with rare exceptions) mutually exclusive.

Can RUO products have a CE mark (under EMC Directive) and carry both CE mark and For RUO only?
Yes. An RUO is in the US system and a CE Mark to the EMC directive is in the EU system. A product could be in both states at the same time.

Your question involves two regulatory systems (US and EU) which are not comparable. They have very different requirements. The conventions in one do not carry over to the other.

In the US system a product is either a "full" IVDs or investigational. There are three categories of investigational: RUO, IUO, and Part 812.

In the US, there are Laboratory Developed Tests, LDTs, which are manufactured by commercial labs, run in the same lab, and used to deliver patient results. The US FDA exercises enforcement discretion, and does not regulate the manufacture of LDTs.

A lab should not purchase an RUO, claim it is an LDT, and use it to deliver patient results. FDA has told some companies that their devices do not qualify as an LDT and cited them in Warning Letters.

In the EU, the situation is very different. Consider the IVDR.

A product is either a device that satisfies all the requirements (and has a CE Mrk) or a product subject to a performance study.

The EU doesn't allow LDTs by commercial labs. Health institutions have an exception for their own use.

Can a company have a CE-IVD mark and still sell RUO versions in the EU lab?
No. In the EU, there are no RUO products. A product has either the CE Mark or is subject to a performance study. They are (with rare exceptions) mutually exclusive.

Can RUO products have a CE mark (under EMC Directive) and carry both CE mark and For RUO only?
Yes. An RUO is in the US system and a CE Mark to the EMC directive is in the EU system. A product could be in both states at the same time.

Your question involves two regulatory systems (US and EU) which are not comparable. They have very different requirements. The conventions in one do not carry over to the other.

In the US system a product is either a "full" IVDs or investigational. There are three categories of investigational: RUO, IUO, and Part 812.

In the US, there are Laboratory Developed Tests, LDTs, which are manufactured by commercial labs, run in the same lab, and used to deliver patient results. The US FDA exercises enforcement discretion, and does not regulate the manufacture of LDTs.

A lab should not purchase an RUO, claim it is an LDT, and use it to deliver patient results. FDA has told some companies that their devices do not qualify as an LDT and cited them in Warning Letters.

In the EU, the situation is very different. Consider the IVDR.

A product is either a device that satisfies all the requirements (and has a CE Mrk) or a product subject to a performance study.

The EU doesn't allow LDTs by commercial labs. Health institutions have an exception for their own use.

Can a company have a CE-IVD mark and still sell RUO versions in the EU lab?
No. In the EU, there are no RUO products. A product has either the CE Mark or is subject to a performance study. They are (with rare exceptions) mutually exclusive.

Can RUO products have a CE mark (under EMC Directive) and carry both CE mark and For RUO only?
Yes. An RUO is in the US system and a CE Mark to the EMC directive is in the EU system. A product could be in both states at the same time.

Your question involves two regulatory systems (US and EU) which are not comparable. They have very different requirements. The conventions in one do not carry over to the other.

In the US system a product is either a "full" IVDs or investigational. There are three categories of investigational: RUO, IUO, and Part 812.

In the US, there are Laboratory Developed Tests, LDTs, which are manufactured by commercial labs, run in the same lab, and used to deliver patient results. The US FDA exercises enforcement discretion, and does not regulate the manufacture of LDTs.

A lab should not purchase an RUO, claim it is an LDT, and use it to deliver patient results. FDA has told some companies that their devices do not qualify as an LDT and cited them in Warning Letters.

In the EU, the situation is very different. Consider the IVDR.

A product is either a device that satisfies all the requirements (and has a CE Mrk) or a product subject to a performance study.

The EU doesn't allow LDTs by commercial labs. Health institutions have an exception for their own use.

Can a company have a CE-IVD mark and still sell RUO versions in the EU lab?
No. In the EU, there are no RUO products. A product has either the CE Mark or is subject to a performance study. They are (with rare exceptions) mutually exclusive.

Can RUO products have a CE mark (under EMC Directive) and carry both CE mark and For RUO only?
Yes. An RUO is in the US system and a CE Mark to the EMC directive is in the EU system. A product could be in both states at the same time.

I don't understand the question, so please you clarify a few points.

Neither the IVDD, IVDR, or FDA use the term "legal manufacturer", only manufacturer. What is the distinction in this case?

You say "legal manufacturer of the product". What is the product?

For example, it could be a kit that includes the item from the OEM. The OEM could sell the item to many people, or it made only for your company.

For example, you could be a distributor for the OEM's item.

Are you selling your product in the US? If you so, the RUO statement will limit the customers.

Are you selling your product in the EU? If so, the product you sell needs the appropriate documentation. That depends on things like IVDD, IVDR, class, whether you are manufacturer or a distributor, etc.

Your question involves two regulatory systems (US and EU) which are not comparable. They have very different requirements. The conventions in one do not carry over to the other.

In the US system a product is either a "full" IVDs or investigational. There are three categories of investigational: RUO, IUO, and Part 812.

In the US, there are Laboratory Developed Tests, LDTs, which are manufactured by commercial labs, run in the same lab, and used to deliver patient results. The US FDA exercises enforcement discretion, and does not regulate the manufacture of LDTs.

A lab should not purchase an RUO, claim it is an LDT, and use it to deliver patient results. FDA has told some companies that their devices do not qualify as an LDT and cited them in Warning Letters.

In the EU, the situation is very different. Consider the IVDR.

A product is either a device that satisfies all the requirements (and has a CE Mrk) or a product subject to a performance study.

The EU doesn't allow LDTs by commercial labs. Health institutions have an exception for their own use.

Can a company have a CE-IVD mark and still sell RUO versions in the EU lab?
No. In the EU, there are no RUO products. A product has either the CE Mark or is subject to a performance study. They are (with rare exceptions) mutually exclusive.

Can RUO products have a CE mark (under EMC Directive) and carry both CE mark and For RUO only?
Yes. An RUO is in the US system and a CE Mark to the EMC directive is in the EU system. A product could be in both states at the same time.