On the 16th of December, the EU published their plans to simplify the existing EU regulatory framework for medical devices and in vitro diagnostic medical devices.
This proposal seeks to streamline and future-proof the EU regulatory framework for medical devices and in vitro diagnostics. Its primary objective is to simplify applicable rules, reduce administrative burdens for manufacturers, and improve the predictability, efficiency, and cost-effectiveness of conformity assessment by notified bodies, while maintaining a high level of public health protection and patient safety.
Although the core objectives of the MDR and IVDR remain valid and are supported by all stakeholders, persistent challenges continue to undermine their effective implementation. In particular, unpredictable certification timelines, divergent practices across Member States, and requirements that are disproportionate to the actual risks posed by certain devices hinder the CE-marking process. These issues result in unnecessary costs and administrative burdens, especially for small and medium-sized enterprises (SMEs). Excessively onerous requirements may lead manufacturers to withdraw devices from the EU market or delay new product launches, with potential negative consequences for patient access, public health, and the global competitiveness of the EU medical technology sector.
The proposal responds to calls from the European Parliament, several Member States, and a wide range of stakeholders for regulatory simplification and measures to safeguard device availability. A new regulation is therefore considered necessary to address the identified shortcomings, which would otherwise have a significant impact on the medical devices market and, ultimately, on the quality of healthcare delivered to patients in the EU.
Some of the notable amendments can be seen tabulated below. Please note that the following list is by no means an exhaustive list and we urge our clients to read the full proposal via the link below.
| Area of Concern | MDR/IVDR Section | Description of Amendment |
| Classification rules | MDR: Annex VIII | Some classification rules are adapted resulting in lower risk classes for certain devices, such as reusable surgical instruments, accessories to active implantable devices and software. |
| Clinical evidence, non-clinical data and clinical data | MDR: Article 2, point 48, Article 61, Annex II, Annex XIV, IVDR: Annex XIII | A wider range of data may qualify as clinical data. The conditions for relying on clinical data of an equivalent device are made more flexible. In Article 61 MDR, the possibility to demonstrate a device’s safety and performance based on non-clinical data alone is expanded. The use of ‘New Approach Methodologies’, such as in silico testing, is promoted |
| Conformity assessment procedures | MDR: Article 52, Annexes IX, X, XI IVDR: Article 48, Annexes IX, X, XI | The involvement of notified bodies in the conformity assessment of lower and medium risk devices (class IIa and IIb and class B and C) will be reduced (technical documentation assessment of one representative device for a generic device group, for a category or for the entire portfolio). No systematic technical documentation assessment of representative devices will be required during surveillance activities. Class A sterile IVD will not require notified body involvement. Notified bodies will have the possibility to replace on-site audits by remote audits. Where justified due to absence of safety issues, surveillance audits should be conducted only every two years. Unannounced audits should be conducted ‘for-cause’. Reduced timelines for consultation of medicinal products and SoHO authorities |
| Validity of certificates and recertification | MDR: Article 56 IVDR: Article 51 | The maximum period of validity of certificates (currently 5 years) is removed. Instead of recertifying devices, notified bodies will carry out periodic reviews proportionate to the risk of the device while the certificate is valid. |
| Notified body fees | MDR: Article 50 | Fee reductions for micro and small manufacturers and for orphan devices. The Commission will be empowered to set level and structure of notified body fees. |
| International cooperation and reliance mechanisms | MDR: new Article 108a and new Article 108b | A new section on international cooperation is introduced promoting activities aiming at global regulatory convergence and international cooperation, such as the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Programme (MDSAP) |
| Well-established technologies | MDR: Article 2, point 72, Article 18, Article 32, Article 52, Article 61, Article 86 | A definition of ‘well-established technology device’ is introduced 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. |
| Regulatory sandboxes | MDR: new Articles 59b and 59c IVDR: new Articles 54b and 54c | Member States and the Commission may establish regulatory sandboxes to address needs of emerging technologies. |
| Authorised Representative | MDR: Article 11(4) IVDR: Article 11(4) | New amendments propose to delete point 4 from Article 11. This implies that the authorised representative can now be mandated for the following tasks: Article 10 (1), (2), (3), (4), (5), (6), (8), (9), (10) and (11). |
The full proposal can be accessed using the following link
