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In February 2023, the EU Commission extended the Notified Body (NB) certificates issued under the MDD (which would be otherwise valid until 26 May 2024 and possible to market on the EU until May 2025).
The extension is until the end of 2027 (for higher-risk devices such as class III and Class IIb implantable) and until the end of 2028 (for the mid and smaller-risk devices which are other class IIb, class IIa, class Im (with measuring function), class Is (sterile) and class Ir (reusable surgical instruments)).
Manufacturers of these medical devices must meet specific criteria such as MDR readiness and an MDR application at a notified body by 26 May 2024.
This extension is intended to give manufacturers more time to achieve compliance with MDR and to “buy” some time for Notified Bodies to process the applications that had amassed towards the end of the grace period.
However, the lowest risk Class I self-certified devices (which are not class Im, Is or Ir, (or up-classified under MDR) are not included in this extension nor were they included in the original extension (grace period) described under Article 120 of MDR.
Therefore, all Class I self-certified devices must fully comply with MDR from 26 May 2021.
The legal manufacturer is responsible for ensuring that product Technical Documentation (TD) is current and compliant with MDR requirements.
TD, which is prepared according to the Directives (MDD) must be updated. Likewise, you should use the most updated and harmonized applicable standards to demonstrate compliance. For example, Notified Bodies and EC REPs expect you to use ISO 14971:2019 to meet risk management requirements; the older 2012 version is no longer acceptable.
As an initial step, we would advise you to undertake a review or gap analysis of your existing technical documentation and compare it against the requirements of the regulation you wish to comply with.
Our experts have a skilled and experienced team of consultants who are ready and able to assist in providing you with a gap analysis service in a cost-effective manner.
Upon completion of the Gap Analysis, BioReg will prepare a comprehensive report highlighting any deficiencies or nonconformities against referenced requirements and providing suggestions for closing these gaps.
In addition, based on our report, we shall provide a quotation to bring your documentation in line with the requirements of the Regulation you wish to comply with.
Such a gap analysis can be applied to your whole technical file or to sections such as the Clinical Evaluation section or Risk Management section, or as you require.
Similarly, a gap analysis can be applied to your Quality Management System (QMS) mainly as there is now a strong link between QMS and the new Regulations.
For more information, please get in touch with the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.