On 5th May 2017, the new EU Medical Devices and In-Vitro Diagnostics Devices Regulations have been finally published in the Official Journal of the European Union. This means that the new Regulations will officially enter into force 20 days after their publication (hence on 25th May 2017) and replace currently existing directives MDD 93/42/EEC, AIMD 90/385/EEC and IVDD 98/79/EC.
Deadlines to comply with new requirements
In practical terms, the transitional provisions and repealing exceptions mentioned in both Regulations are very complex and might still leave some room for interpretation. As far as the Medical Devices are concerned, the new Regulation will apply 3 years after entry into force, hence on the 25th May 2020, whilst for the In-Vitro Diagnostics Devices, the period of 5 years is foreseen before entry into force hence on 25th May 2022. Some exceptions are foreseen for earlier or later entry into force for several other provisions such as for example Notified Bodies designation, device registration or CE certificates validity. Given numerous changes in the compliance process, especially for high-risk devices, manufacturers are strongly advised to start implementing new requirements as soon as possible in order to safeguard their products’ EU compliance.
Texts available on Obelis website
The final consolidated texts of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices are now available on the Obelis website on our Legislation page. Feel free to review the final texts and should you have any questions or wish to know more about new provisions brought about by the new Regulations, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly answer any question you may have and will gladly assist you in safeguarding your devices’ compliance.
Katarzyna Piekarska