How the new IVDR affects Thermo Scientific pipettes and pipette tips?

European IVD Regulation 2017/746 replaces the IVD Directive 98/79/EC in May 2022. Due to this change, we are removing the CE-IVD marking from our manual pipette portfolio and compatible pipette tips. The new IVD regulation clarifies the product classification and states that pipettes and tips should be “for general laboratory use” going forward. The change will take place in our production during March 2022.

There will be no change to our product quality, fit and form. We will continue to use the same product codes as currently. The same high standard quality systems will continue to be used in our manufacturing facilities. These general laboratory use pipettes and tips can continue to be used in all general laboratory applications including IVD as before.

Pipettes effected

Finnpipette F1

4641010N

Finnpipette F1 0,2-2 µl µTip

4641020N

Finnpipette F1 0,5-5 µl µTip

4641030N

Finnpipette F1 1-10 µl µTip

4641040N

Finnpipette F1 1-10 µl

4641050N

Finnpipette F1 2-20 µl µTip

4641060N

Finnpipette F1 2-20 µl

4641130N

Finnpipette F1 5-50 µl µTip

4641140N

Finnpipette F1 5-50 µl

4641070N

Finnpipette F1 10-100 µl

4641080N

Finnpipette F1 20-200 µl

4641090N

Finnpipette F1 30-300 µl

4641100N

Finnpipette F1 100-1000 µl

4641110N

Finnpipette F1 0,5-5 ml

4641120N

Finnpipette F1 1-10 ml

4651020N

 Finnpipette F1 Fixed Volume 10µl

4651130N

 Finnpipette F1 Fixed Volume 20µl

4651030N

 Finnpipette F1 Fixed Volume 25µl

4651040N

 Finnpipette F1 Fixed Volume 50µl

4651050N

 Finnpipette F1 Fixed Volume 100µl

4651140N

 Finnpipette F1 Fixed Volume 200µl

4651060N

 Finnpipette F1 Fixed Volume 250µl

4651070N

 Finnpipette F1 Fixed Volume 500µl

4651080N

 Finnpipette F1 Fixed Volume 1000µl

4651090N

 Finnpipette F1 Fixed Volume 2ml

4651100N

 Finnpipette F1 Fixed Volume 3ml

4651110N

 Finnpipette F1 Fixed Volume 5ml

4651120N

 Finnpipette F1 Fixed Volume 10ml

4661000N

 Finnpipette F1 8-ch 1-10µl

4661010N

 Finnpipette F1 8-ch 5-50µl

4661020N

 Finnpipette F1 8-ch 10-100µl

4661030N

 Finnpipette F1 8-ch 30-300µl

4661040N

 Finnpipette F1 12-ch 1-10µl

4661050N

 Finnpipette F1 12-ch 5-50µl

4661060N

 Finnpipette F1 12-ch 10-100µl

4661070N

 Finnpipette F1 12-ch 30-300µl

4661080N

 Finnpipette F1 16-ch 1-10µl

4661090N

 Finnpipette F1 16-ch 5-50µl

Finnpipette F2

4642010

Finnpipette F2 0.2-2µl

4642020

Finnpipette F2 0.5-5µl

4642030

Finnpipette F2 1-10µl µTip

4642040

Finnpipette F2 1-10µl

4642050

Finnpipette F2 2-20µl µTip

4642060

Finnpipette F2 2-20µl

4642120

Finnpipette F2 5-50µl µTip

4642130

Finnpipette F2 5-50µl

4642070

Finnpipette F2 10-100µl

4642080

Finnpipette F2 20-200µl

4642090

Finnpipette F2 100-1000µl

4642100

Finnpipette F2 0.5-5ml

4642110

Finnpipette F2 1-10ml

4652000

Finnpipette F2 Fixed 1µl µTip

4652010

Finnpipette F2 Fixed 5µl µTip

4652020

Finnpipette F2 Fixed 10µl

4652130

Finnpipette F2 Fixed 20µl

4652030

Finnpipette F2 Fixed 25µl

4652040

Finnpipette F2 Fixed 50µl

4652050

Finnpipette F2 Fixed 100µl

4652140

Finnpipette F2 Fixed 200µl

4652060

Finnpipette F2 Fixed 250µl

4652070

Finnpipette F2 Fixed 500µl

4652080

Finnpipette F2 Fixed 1000µl

4652090

Finnpipette F2 Fixed 2ml

4652100

Finnpipette F2 Fixed 3ml

4652150

Finnpipette F2 Fixed 4ml

4652110

Finnpipette F2 Fixed 5ml

4652120

Finnpipette F2 Fixed 10ml

4662000

Finnpipette F2 8-ch 1-10µl

4662010

Finnpipette F2 8-ch 5-50µl

4662020

Finnpipette F2 8-ch 10-100µl

4662030

Finnpipette F2 8-ch 30-300µl

4662040

Finnpipette F2 12-ch 1-10µl

4662050

Finnpipette F2 12-ch 5-50µl

4662060

Finnpipette F2 12-ch 10-100µl

4662070

Finnpipette F2 12-ch 30-300µl

4662080

Finnpipette F2 16-ch 1-10µl

4662090

Finnpipette F2 16-ch 5-50µl

Finnpipette F3

4640000

Finnpipette F3 1-10µl µTip

4640010

Finnpipette F3 1-10µl

4640020

Finnpipette F3 2-20µl µTip

4640030

Finnpipette F3 2-20µl

4640080

Finnpipette F3 5-50µl µTip

4640090

Finnpipette F3 5-50µl

4640040

Finnpipette F3 10-100µl

4640050

Finnpipette F3 20-200µl

4640060

Finnpipette F3 100-1000µl

4640100

Finnpipette F3 0.5-5ml

4640070

Finnpipette F3 1-10ml

4640110

Finnpipette F3 0.2-2µl µTip

4650000

Finnpipette F3 Fixed 1µl µTip

4650010

Finnpipette F3 Fixed 5µl µTip

4650020

Finnpipette F3 Fixed 10µl

4650030

Finnpipette F3 Fixed 25µl

4650040

Finnpipette F3 Fixed 50µl

4650050

Finnpipette F3 Fixed 100µl

4650060

Finnpipette F3 Fixed 250µl

4650070

Finnpipette F3 Fixed 500µl

4650080

Finnpipette F3 Fixed 1000µl

4650090

Finnpipette F3 Fixed 20µl

4650100

Finnpipette F3 Fixed 200µl

4660010

Finnpipette F3 8-ch 5-50µl

4660020

Finnpipette F3 8-ch 30-300µl

4660040

Finnpipette F3 12-ch 5-50µl

F1-ClipTip

4641310N

F1-ClipTip 0.1-2 µl

4641320N

F1-ClipTip, 1-10 µl

4641180N

F1-ClipTip, 2-20 µl

4641190N

F1-ClipTip, 5-50 µl

4641200N

F1-ClipTip, 10-100 µl

4641210N

F1-ClipTip, 20-200 µl

4641220N

F1-ClipTip, 30-300 µl

4641230N

F1-ClipTip, 100-1000 µl

4651280N

F1-ClipTip, Fixed 10 µl

4651200N

F1-ClipTip, Fixed 20 µl

4651210N

F1-ClipTip, Fixed 25 µl

4651220N

F1-ClipTip, Fixed 50 µl

4651230N

F1-ClipTip, Fixed 100 µl

4651240N

F1-ClipTip, Fixed 200 µl

4651250N

F1-ClipTip, Fixed 250 µl

4651260N

F1-ClipTip, Fixed 500 µl

4651270N

F1-ClipTip, Fixed 1000 µl

4661210N

F1-ClipTip 8-ch 1-10 µl

4661120N

F1-ClipTip 8-ch 5-50 µl

4661130N

F1-ClipTip 8-ch 10-100 µl

4661140N

F1-ClipTip 8-ch 30-300 µl

4661220N

F1-ClipTip 12-ch 1-10 µl

4661160N

F1-ClipTip 12-ch 5-50 µl

4661170N

F1-ClipTip 12-ch 10-100 µl

4661180N

F1-ClipTip 12-ch 30-300 µl

Pipettes tips effected

Finntip

9400100

Finntip 200 Ext, 400/box

9400130

Finntip 200 Ext, 10x96/rack

9400133

Finntip 200 Ext, 10x96/rack, sterile

9400220

Finntip 250 Universal, 20000/bµlk

9400230

Finntip 250 Universal, 1000/bag

9400250

Finntip 250 Universal, 500/box

9400260

Finntip 250 Universal, 10x96/rack

9400263

Finntip 250 Universal, 10x96/rack, sterile

9400266

Finntip 250 Universal, refill starter kit, 10x96/refill+4x96/rack

9400267

Finntip 250 Universal, 20x96/refill kit

9400300

Finntip 10, 10x96/rack

9400303

Finntip 10, 10x96/rack, sterile

9400310

Finntip 10, 1000/bag

9400326

Finntip 10, refill starter kit, 10x192/refill+4x192/rack

9400327

Finntip 10, 20x192/refill kit

9400360

Finntip 50, 1000/bag

9400370

Finntip 50, 10x384/rack

9400373

Finntip 50, 10x384/rack, sterile

9400610

Finntip 20, 10x384/rack

9400613

Finntip 20, 10x384/rack, sterile

9400620

Finntip 20, 1000/bag

9401010

Finntip 1000, 10000/bµlk

9401030

Finntip 1000, 1000/bag

9401070

Finntip 1000, 200/box

9401110

Finntip 1000, 10x96/rack

9401113

Finntip 1000, 10x96/rack, sterile

9401115

Finntip 1000, 5x192/refill pack

9401240

Finntip 300, 20000/bµlk

9401250

Finntip 300, 10x96/rack

9401253

Finntip 300, 10x96/rack, sterile

9401255

Finntip 300, 10x192/refill pack

9401260

Finntip 300, 1000/bag

9401410

Finntip 1000 Ext, 1000/bag

9401420

Finntip 1000 Ext, 5x96/rack

9401423

Finntip 1000 Ext, 5x96/rack, sterile

9402010

Finntip 5 ml, 3000/bµlk

9402030

Finntip 5 ml, 500/bag

9402050

Finntip 5 ml, 75/box

9402070

Finntip 5 ml, 5x54/rack

9402073

Finntip 5 ml, 5x54/rack, sterile

9402150

Finntip 10 ml, 40/box

9402151

Finntip 10 ml, 100/bag

9402160

Finntip 10 ml, 5x24/rack

9402163

Finntip 10 ml, 5x24/rack, sterile

9405020

Finntip 250 Wide, 1000/bag

9405030

Finntip 250 Wide, 22000/bµlk

9405050

Finntip 1000 Wide, 400/bag

9405060

Finntip 1000 Wide, 6500/bµlk

9405120

Finntip 250 Wide, 10x96/rack

9405123

Finntip 250 Wide, 10x96/rack, sterile

9405160

Finntip 1000 Wide, 10x96/rack

9405163

Finntip 1000 Wide, 10x96/rack, sterile

Finntip Filter

94052000

Finntip Filter 10µl Micro, 10x96/rack, sterile

94052020

Finntip Filter 20µl, 10x384/rack, sterile

94052060

Finntip Filter 50µl, 10x384/rack, sterile

94052100

Finntip Filter 10µl, 10x96/rack, sterile

94052150

Finntip Filter 20µl, 10x96/rack, sterile

94052160

Finntip Filter 30µl, 10x96/rack, sterile

94052200

Finntip Filter 100µl, 10x96/rack, sterile

94052300

Finntip Filter 200µl, 10x96/rack, sterile

94052310

Finntip Filter 100µl Ext, 10x96/rack, sterile

94052320

Finntip Filter 200µl Ext, 10x96/rack, sterile

94052350

Finntip Filter 300µl, 10x96/rack, sterile

94052410

Finntip Filter 1000µl, 10x96/rack, sterile

94052430

Finntip Filter 1000µl Ext, 5x96/rack, sterile

94052450

Finntip Filter 1500µl 10x96/rack, sterile

94052550

Finntip Filter 5ml, 5x54/rack, sterile

94052600

Finntip Filter 10ml, 5x24/rack, sterile

Finntip Flex Filter

94056380

Finntip Flex Filter 200µl, 10x96/rack, sterile

94056510

Finntip Flex Filter 30µl, 10x96/rack, sterile

94056520

Finntip Flex Filter 100µl, 10x96/rack, sterile

94056580

Finntip Flex Filter 300µl, 10x96/rack, sterile

94056710

Finntip Flex Filter 1000µl, 10x96/rack, sterile

94056810

Finntip Flex Filter 1200µl, 10x96/rack, sterile

94056970

Finntip Flex Filter 10ml Ext, 50/bag, sterile

94056980

Finntip Flex Filter 10µl, 10x96/rack, sterile

Finntip Flex

94060100

Finntip Flex 10, 10x96/rack

94060103

Finntip Flex 10, 10x96/rack, sterile

94060116

Finntip Flex 10, refill starter kit, 20x96/refill+1x96/rack

94060117

Finntip Flex 10, 20x96/refill kit

Product Code

Description

94060120

Finntip Flex 10, 1000/bag

94060310

Finntip Flex 200, 10x96/rack

94060313

Finntip Flex 200, 10x96/rack, sterile

94060316

Finntip Flex 200, refill starter kit, 20x96/refill+1x96/rack

94060317

Finntip Flex 200, 20x96/refill kit

94060320

Finntip Flex 200, 1000/bag

94060510

Finntip Flex 300, 10x96/rack

94060513

Finntip Flex 300, 10x96/rack, sterile

94060516

Finntip Flex 300, refill starter kit, 20x96/refill+1x96/rack

94060517

Finntip Flex 300, 20x96/refill kit

94060520

Finntip Flex 300, 1000/bag

94060710

Finntip Flex 1000, 10x96/rack

94060713

Finntip Flex 1000, 10x96/rack, sterile

94060716

Finntip Flex 1000, refill starter kit, 16x96/refill+1x96/rack

94060717

Finntip Flex 1000, 16x96/refill kit

94060720

Finntip Flex 1000, 1000/bag

94060810

Finntip Flex 1200, 10x96/rack

94060813

Finntip Flex 1200, 10x96/rack, sterile

94060816

Finntip Flex 1200, refill starter kit, 16x96/refill+1x96/rack

94060817

Finntip Flex 1200, 16x96/refill kit

94060820

Finntip Flex 1200, 1000/bag

94060970

Finntip Flex 10 ml Ext, 100/bag

94060973

Finntip Flex 10 ml Ext, 50/bag, sterile

ClipTip Tips

94410210

ClipTip 20, 10x96/rack

94410213

ClipTip 20, 10x96/rack, Sterile

94410217

ClipTip 20 Reload Tower, 10x96/insert

94410218

ClipTip 20 Reload Tower, 10x96/insert, Sterile

94410250

ClipTip 50, 10x96/rack

94410253

ClipTip 50, 10x96/rack, Sterile

94410257

ClipTip 50 Reload Tower, 10x96/insert

94410258

ClipTip 50 Reload Tower, 10x96/insert, Sterile

94410310

ClipTip 200, 10x96/rack

94410313

ClipTip 200, 10x96/rack, Sterile

94410317

ClipTip 200 Reload Tower, 10x96/insert

94410318

ClipTip 200 Reload Tower, 10x96/insert, Sterile

94410510

ClipTip 300, 10x96/rack

94410513

ClipTip 300, 10x96/rack, Sterile

94410517

ClipTip 300 Reload Tower, 10x96/insert

94410518

ClipTip 300 Reload Tower, 10x96/insert, Sterile

94410710

ClipTip 1000, 8x96/rack

94410713

ClipTip 1000, 8x96/rack, Sterile

94410717

ClipTip 1000, Reload Tower, 8x96/insert

94410718

ClipTip 1000, Reload Tower, 8x96/insert, Sterile

94410060         

ClipTip 12.5 Ext, 10x96/rack

94410063         

ClipTip 12.5 Ext, 10x96/rack, Sterile

94410610

ClipTip 300 Ext, 8x96/rack

94410613

ClipTip 300 Ext, 8x96/rack, Sterile

94410617

ClipTip 300 Ext, Reload Tower, 8x96/insert

94410618

ClipTip 300 Ext, Reload Tower, 8x96/insert Sterile

94410619

ClipTip 300 Ext Empty Rack

ClipTip Filter Tips

94420213

ClipTip 20 Filter, Racked, Sterile

94420253

ClipTip 50 Filter, Racked, Sterile

94420313

ClipTip 200 Filter, Racked, Sterile

94420513

ClipTip 300 Filter, Racked, Sterile

94420713

ClipTip 1000 Filter, 8x96/rack, Sterile

94420063         

ClipTip 12.5 Ext Filter, 10x96/rack, Sterile

94420613

ClipTip 300 Ext Filter, 8x96/rack, Sterile

Download the following articles for further details.

Questions and Answers

1. I don’t need CE-IVD marking on my pipette and tips but I would like to have a CE-mark on them. Is this possible?

CE-marking is required for many products sold in EU as an indication that manufacturer has made sure the product is safe to use for its intended use and product is in compliance with EU legislation related to safety, health and environmental topics. However, not ALL products sold in EU require a CE-marking. There are specific EU directives/regulations that require the marking but it’s forbidden to affix CE marking to other products. So there always is a specific EU directive behind the CE-mark it refers to such as IVD devices (2017/746/EU), Low Voltage Directive (2014/35/EU) for electronic devices or toys (2009/48/EC). Pipettes and tips are considered general laboratory use products and there’s no directive for those, so CE-marking is not possible for general laboratory use pipettes going forward.

2. Are there any differences between the previous CE-IVD marked pipettes and tips and the ones without CE mark?

There are no differences in quality, technical design or in performance. The only change is the physical removal of the CE mark which will no longer be found on the products and package labels.

3. Does the change affect the regulatory status of CE-IVD pipettes and tips that I already own?

No. The regulatory status of all pipettes that were/are affixed with the CE-IVD mark stays as it is. The products may be used accordingly until the end of their lifetime.

4. What tips should I use with the CE-IVD marked Thermo Scientific™ manual pipettes if I can no longer purchase CE-IVD marked compatible tips?

You should continue to use the same Thermo Scientific tips you have used before. The performance is still guaranteed and there’s no change in quality, performance or function.

5. Can I use non CE-IVD marked pipettes and tips for diagnostic applications?

Yes, there’s no regulation saying that all items in diagnostic laboratories need to be CE-IVD marked. System level validation has always been the responsibility of the laboratory that performs diagnostics and that includes making sure the tools and accessories used to perform a diagnostic test are fit for the system needs. Additionally, it should be ensured that users are regularly trained to handle piston-operated pipettes and that the pipettes are  calibrated and serviced regularly.

6. Will the CE-marking be removed also from electronic pipettes?

No. Electronic devices require to fulfill certain EU directives such as e.g. Low Voltage Directive (2014/35/EU) and Electromagnetic Compatibility Directive (2014/30/EU) that we continue to follow in order to guarantee the safety of our electronic devices and proceed to apply CE-marking accordingly.

Style Sheet for Global Design System