From Directive to Regulation meaning that it will now be enforceable by law in all Member States.

Three Medical Device Directives evolve into two Regulations:

• Medical Device Directive (MDD) & Active Implantable Medical Device Directive (AIMD) are now covered by one Medical Device Regulation (MDR): Date of application = 3 years after entry into force i.e. 26 May 2020
• In-Vitro Diagnostics Directive (IVDD) is now covered by In-Vitro Diagnostics Regulation (IVDR): Date of application = 5 years after entry into force i.e. 26 May 2022

MDR [Regulation (EU) 2017/745] – Contents:

• Part A: Introduction – Reasoning
• Part B: Main content (10 Chapters of 123 Articles)
• Part C: Guidelines & Examples – XVII Annexes

Some Key Regulatory and Medical Documents required:

• Clinical Evaluation Reports (CERs): Increased stringency and frequency of updates for certain classes [MDR Article 61].
• Clinical Trial Documents: Due to increased clinical trials required for CE marking and/or recertification, it will be expected to submit more clinical investigation plans and reports (i.e. study protocols and reports) [MDR Articles 61 & 62].
• Post-marketing documents: Post-market surveillance plans [MDR Article 84] and reports [MDR Article 85] will need to be submitted for all classes.
• Periodic Safety update reports (PSUR): For Class IIa devices, PSURs will need to be submitted every 2 years and annually for class IIb and III devices [MDR Article 86].
• Summary of safety and clinical performance (SSCP): For implantable devices, class III and other investigational devices, it will be required to submit SSCP which will be available to the public and therefore, prepared accordingly for the attention of the intended device user and/or patient [MDR Article 32].

Please note that many important changes which are not within the scope of this article have been implemented with the new regulations. Key opinion leaders predict that some changes will in turn show a great impact on how devices are marketed and some other changes which are currently described as unpredictable may further disrupt the medical device market.

Niconex Medical will remain constantly updated with developments to provide complete regulatory and medical support should it be required.