How many kinds of Well-Established Technology?!
There are now four kinds of well established technology under MDR. This article walks through the journey, and the current position, and the proposed changes to MDR.
The original MDR position
In the beginning of MDR, there was one definition of well-established technology (WET). Article 18 (implant cards), Article 52 (conformity assessment procedures), and Article 61 (clinical evaluation) all referred to the following list:
sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors
Therefore when we talked about WET devices, everything was clear. We were working from a single definition.
Under Article 18(3), this list of devices were exempt from the obligations of Article 18, therefore not having to provide an implant card or the related “rapidly accessible” information for an implantable device on that list.
Under Article 52(4), this list of devices were exempt from assessment of the technical documentation for every device (i.e. are subject to technical documentation sampling as a group of devices).
Under Article 61(6), this same list of devices were exempt from the Article 61(4) requirement that implantable and Class III devices shall have clinical investigations1.
Evolved by guidance
In April 2020 MDCG 2020-6 was published, with regard to clinical evidence needed for legacy devices. This gave us the following definition:
The common features of the devices which are well- established technologies are that they all have:
*o relatively simple, common and stable designs with little evolution; * o their generic device group has well-known safety and has not been associated with safety issues in the past;
o well-known clinical performance characteristics and their generic device group are standard of care devices where there is little evolution in indications and the state of the art;
o a long history on the market.
This caused no end of confusion. I worked at a leading notified body at the time, and we received plenty of questions querying whether devices could be down-classified as a result.
However, the guidance did not change the legal wording in Articles 52 or 61. Therefore, the WET devices that were exempt from full assessment of technical documentation and clinical investigation did not change.
Where the MDCG 2020-6 definition was used was exclusively within clinical evaluation reports (CERs). If you could justify that your legacy device falls within this definition, it was possible to justify requiring a lower level of clinical evidence to demonstrate conformity.
Developments in 2026
On 29th June 2026, Commission Delegated Regulation (EU) 2026/1359 added to the list of devices in Article 52(4). Now, the following devices are exempted from assessment of the technical documentation for every device (i.e. are subject to sampling from a group):
(a) sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors,
(b) cannulas, catheters, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, suspensory fixations and cinches.
Notice anything strange about this list? Following the wording of Article 52(4), it should be a list of Class IIb implantable devices. I can spot at least a few non-implantable devices in that list.
On the same day, Commission Delegated Regulation (EU) 2026/1451 added different devices to the list of devices in Article 61(6). This is now the list of devices that are exempt from the Article 61(4) requirement that implantable and Class III devices shall have clinical investigations1.
(a) sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, connectors,
(b) cranial perforators, cranio-blades, catheter passers, patties and strips, magnets for implantable pulse generators, port plugs, stylets and stylet guides, needles, needle holders, forceps, cannulas, atrioseptostomy balloon catheters, catheters coated with anticoagulants, blood bags incorporating anticoagulants, port catheters, introducers, dilators, ventricular drains, feeding tubes, suture pledgets, suture sleeves, suture buttons, gastrostomy buttons, bone tacks, bone wax, bone fillers, bone substitutes, stem centralisers, diaphyseal obturators, radiography markers, fiber ligatures, tubal extraluminal ligation devices, transpalatal distractors, nails, anchors, spinal posterior fixations, textile braids, dental implants, orthodontic devices, dental barriers, dental veneers, suspensory fixations and cinches, reusable surgical instruments, springs for skull enlargement, guidewires, pressure wires, pacing wires and leads, snares, lead caps, fixation and connector tools, endovascular embolisation coils, embolisation particles, cables, shunts and internal defibrillation paddles.
Like the Article 52(4) list, the Article 61(6) list has an internal inconsistency too. It should be a list of implantable and class III devices. There are all manner of devices in the new list that are neither implantable nor class III!
The current position
So, now we have four definitions of well-established technology:
- Article 18(3) WET: For determining if the manufacturer shall provide an implant card and associated information with an implantable device. Unchanged from the original MDR list.
- Article 52(4) WET: For determining if class IIb implantable devices should have an assessment of the technical documentation for every device, or only require assessment for at least one representative device per generic device group.
- Article 61(6) WET: For determining if a clinical investigation shall be performed for implantable and Class III devices, or be exempted from this requirement1.
- MDCG 2020-6 WET: For determining if a legacy device can be characterised as a “standard of care” device, setting the context of the device within the state of the art, and paving the way for the justification to accept a lower level of clinical evidence.
Future changes
In December 2025, the EU Commission published their Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices. This includes:
A definition of ‘well-established technology device’ … for devices which will be subject to more proportionate requirements, replacing the lists of devices in the current Articles 18(3), 52(4) and 61(6)(b) MDR.
Reading further into the proposal, we find that the proposed definition is very similar to the MDCG 2020-6 definition:
(72) ‘well-established technology device’ means a device that belongs to a generic device group, which fulfils the following criteria:
(a) it has simple, common and stable design;
(b) it has not been associated with safety issues in the past;
(c) it has well-known clinical performance characteristics and comprises standard of care devices with little evolution in indications and the state of the art;
(d) it has a long history on the Union market;
The proposal includes wording that removes the lists of devices, replaced by reference to the defined well-established technology, in Articles 18, 52 and 61.
It remains to be seen when the proposed amendments will be implemented, but there is light at the end of the tunnel of this WET definition madness.
Note 1: the exemption does not mean that you never need to do a clinical investigation - you should still evaluate if it is required based on the novelty, risk and available clinical data for the device.
Struggling to navigate EU MDR? Brightbark Cranberry can be your partner for success. Find out more at why choose us, read more about our consulting services for regulatory affairs, or get in touch.