Medical devices can be categorized based on MDR (Medical Device Regulation) codes or IVDR (In Vitro Diagnostic Regulation) codes. These codes identify the type of design, intended purpose, characteristics, technologies, processes of the device, or the device use in clinical, laboratory or examination procedures for the device. To become designated as a notified body, organisations must demonstrate competence to these codes. Therefore, notified bodies are only able to conduct conformity assessments for devices and codes they are designated for (i.e. if a notified body does not have the code MDN 1104, they will not be able to assess non-active soft tissue implants). Manufacturers should ensure that the notified body they are engaging with has the appropriate codes needed for their devices. The designation scope of each notified body can be found on the NANDO website.
Additionally, organisations may offer different services. For example, a notified body may be accredited to conformity assess against ISO 13485, but not to the EU MDR or IVDR.
The EU Declaration of Conformity is a legal document where the manufacturer declares that a medical device complies with the requirements of MDR 2017/745 or IVDR 2017/746. This is required for all medical devices regardless of whether a notified body is involved in the conformity assessment.
The following table details the current transition timelines for medical devices and IVDs.
| Classification | Applied to a notified body | Written agreement from notified body | Transition ends |
| Class III and custom-made implantable | 26 May 2024 | 26 September 2024 | 31 December 2027 |
| Devices covered by a valid MDD/AIMDD certificate (valid as 20 March 2023) that are class III, class IIb implantable devices (excluding well-established technologies) | 26 May 2024 | 26 September 2024 | 31 December 2027 |
| Devices covered by a valid MDD/AIMDD certificate (valid as 20 March 2023) that are class IIb (excluding class IIb implantable non-well-established technologies), or class IIa, or class I sterile, or class I measuring | 26 May 2024 | 26 September 2024 | 31 December 2028 |
| Device that did not require notified body certification under the MDD and for which the declaration of conformity was drawn up prior to 26 May 2021 (but now require notified body certification) | 26 May 2024 | 26 September 2024 | 31 December 2028 |
| Devices covered by a valid IVDD certificate | 26 May 2025 | 26 September 2025 | 31 December 2027 |
| Class D | 26 May 2025 | 26 September 2025 | 31 December 2027 |
| Class C | 26 May 2026 | 26 September 2026 | 31 December 2028 |
| Class B and A-sterile | 26 May 2027 | 26 September 2027 | 31 December 2029 |
Note that classifications for medical devices are based on the classification of the device under the MDD or AIMDD. For IVDs, the classification is based on classifications under the IVDR.
The time taken to conduct conformity assessment is variable dependent on numerous factors including the novelty, complexity, risk level, and capacity of the notified body. Typically, it can take between 9 months to 24 months for conformity assessment to be completed, but in some cases may be longer.
The cost of achieving compliance to the MDR and IVDR is variable dependent on numerous factors including the novelty, complexity, risk level, notified body chosen, and the expertise involved with the device. Notified bodies are required to publish their fees, and these can usually be found on each organizations’ website.
Designated notified bodies are listed on the NANDO website. This can be filtered for each legislation to identify notified bodies designated under the MDR and notified bodies designated under the IVDR.
The following devices require conformity assessment by a notified body:
- Class I sterile/measuring medical devices
- Class A sterile in vitro diagnostic devices
- Class IIa medical devices
- Class B in vitro diagnostic devices
- Class IIb medical devices
- Class C in vitro diagnostic devices
- Class III medical devices
- Class D in vitro diagnostic devices
The above diagram provides a general overview of the conformity assessment process. Note: some aspects may be done simultaneously, and this is therefore not always a linear process.
Many notified bodies have published guidance on technical documentation submissions. These guidance documents are usually located on their own websites. Additionally, Team NB regularly hosts training sessions on technical documentation preparation which includes information on what is expected and common pitfalls made by manufacturers.
The time taken to conduct conformity assessment is variable dependent on numerous factors including the novelty, complexity, risk level, and capacity of the notified body. Typically, it can take between 9 months to 24 months for conformity assessment to be completed, but in some cases may be longer.
Some notified bodies offer expedited services which can decrease the time taken to gain certification.
The MDR and IVDR have introduced higher scrutiny for medical devices and IVDs. The European Commission have published multiple resources discussing these changes in detail.
Harmonised standards are standards which can be used to demonstrate conformity to legislation. The full list of harmonised standards for the MDR can be found here, and the full list of harmonised standards for the IVDR can be found here. It is not mandatory for manufacturers to use harmonised standards, but use is encouraged.
Verification is confirmation of meeting specified requirements for a device (i.e. has the device been made correctly) whereas validation is confirmation of meeting a specific intended use or application (i.e. does the device do what it is meant to do).
Verification and validation are both important throughout the conformity assessment process to ensure a complete understanding of the device, in addition to demonstrating a robust quality management system.
The involvement of an EURL is mandatory under IVDR 2017/746 for Class D IVDs. EURLs verify the performance of Class D devices and compliance with common specifications, and performance batch testing of Class D devices.
Article 100 of IVDR 2017/746 provides more information on EURLs, including listing their tasks. Commission Implementing Regulation (EU) 2022/948 also provides the tasks and criteria for EURLs.
Under MDR 2017/745 and IVDR 2017/746, in-house devices are medical devices manufactured and used within a single healthcare institution. Article 5(5) of MDR 2017/745 and IVDR 2017/746 list the conditions to placing these products on the market. A notified body would not be involved in the conformity assessment.
However, these devices are required to be manufactured and used under an appropriate quality management system. Although not a requirement, a manufacturer could choose to undergo certification of ISO 13485 which would involve a notified body review.
Regulation (EU) 2023/607 amended the transition timeline for medical devices. MDCG 2021-25 (Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and
to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC) provides guidance on the requirements for medical devices throughout the transition periods.
Regulation (EU) 2024/1860 amended the transition timeline for IVDs. MDCG 2022-8 (Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 27 May 2022 in accordance with Directive 98/79/EC) provides guidance on the requirements for IVD devices throughout the transition periods.
IMDRF is a group of global medical device regulators who work together to accelerate international medical device regulatory harmonisation and convergence. The current members are Australia, Brazil, Canada, China, European Union, Japan, Russie, Singapore, South Korea, United Kingdom and United Stated of America.
More information can be found on the IMDRF website.
Under MDR 2017/745, contact lenses can be classified as Class IIa, Class IIb, or Class III medical devices depending on their intended use and duration of contact. The classification dictates the required conformity assessment procedures. Class IIa, IIb and III devices require notified body involvement for conformity assessment.
Contact lenses may also be regulated under Annex XVI of MDR 2017/745 where they do not have an intended medical purpose. These products also require notified body involvement for conformity assessment.
EMDN is a nomenclature system for use by manufacturers when registering their medical devices in the Eudamed database which allows allocation of a device description. MDCG has published guidance on EMDN:
- The EMDN – The nomenclature of use in EUDAMED
- MDCG 2021-12: FAQ on the European Medical Device Nomenclature (EMDN)
- MDCG 2024-2: Procedures for the updates of the EMDN
The MDCG provides guidance documents that help clarify the interpretation and application of MDR 2017/745 and IVDR 2017/746 regulations. These guidelines are intended to harmonize practices and ensure that stakeholders interpret and apply the regulatory requirements consistently across the EU.