MedTech Regulatory Updates in EU
16/12/2022
Since December 01 2022 – the MDCG and the European Commission have made some tremendous developments in MDR.
As we all know, the EU Commission has amended MDD to MDR transition Dates which has lead to several movements in the regulations.
On 06th December 2022 – MDCG 2022 17 a position paper on Hybrid Audits was published. This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under EU MDR/IVDR.
Important Note - A ‘hybrid audit’ should be understood as an audit on the premises of the manufacturer or its supplier(s) and/or subcontractor(s) with at least one auditor present on the premises and other members of the audit team participating from elsewhere using information and communication technologies (ICT).
Find the entire publication by clicking here
On the same day - Directorate-General for Health and Food Safety published Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 – There are some clarified and enhanced versions of the rules that need to be followed by the EU member states. Find complete publication by clicking here
The above rules were laid down specifically for the Application of Medical Device Regulation.
A rather active day, the Directorate-General for Health and Food Safety published Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017/745 Click here to read the complete publication
This document was published to lay down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation. Read an Update from our experts
On the 9th December 2022 – MDCG published a Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate Click Here to read the publication
Important Notes
- This document applies to devices that, after the MDR’s respective date of application, have fallen within the scope of Article 120(3) MDR and are or were considered to be ‘legacy devices’
- It only applies to devices that are ‘in transition’ from the MDD or AIMDD to the MDR or, respectively, for which, despite reasonable efforts undertaken by the manufacturer to obtain certification under the MDR, the relevant conformity assessment procedure involving a notified body has not been concluded in time.
- If the Competent Authority, after having performed the evaluation according to Article 94 MDR, comes to the conclusion that the conditions to apply Article 97(1) MDR are met, it should issue a written communication to the manufacturer, or its authorised representative, requiring the manufacturer to bring the device concerned into compliance within the defined period of time.
On 12th December MDCG published 2022-19 Performance study application/notification documents under Regulation (EU) 2017/746
This document is relevant to In-Vitro Diagnostics Manufacturers abiding to EU IVDR and lists down templates for
- Performance Study
- Additional Performance Device
- Additional Comparator Device
- Additional Sites
- Performance Study Supporting Documents
- GSPR Checklists
Experts at Med-Di-Dia can help you navigate all of these Regulatory Requirements. Please feel free to connect with our experts by sending an email to mdd@mddltd.com and we shall arrange one FREE 30 min consultation.
On December 14th MDCG 2022-20 Substantial modification of performance study under Regulation (EU) 2017/746 was published. This is relevant to EU IVDR. Entire Publication can be found by clicking here
This document is intended to be facilitative and its use by the competent authorities and sponsors is encouraged, however it is important to check with the individual Member State in which the performance study is planned to be conducted for any specific national requirements. It is foreseen that this template will be withdrawn once the EUDAMED module for performance studies is fully functional.
On 15th December Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 was published. The First Version was published on 13/09/2022 – Update from our Experts
Version 2 Document can be found here
Manufacturers are often worried and confused when these guidance, position papers, amendments are published by the regulators.
How about you utilising this time to relax and focus on ‘other aspects’ while our Regulatory experts ace all the regulatory and quality requirements for your Medical Devices, Diagnostics and Digital Health?
Seek expert support. Cut to the Chase and Navigate the Regulatory Maze with Med-Di-Dia – Your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!
Send an email to mdd@mddltd.com
