Implementation of the new EU Medical Devices Regulations
The Competent Authorities for Medical Devices (CAMD) Executive Group recommended the establishment of an Implementation Taskforce for the new EU Regulations for Medical Devices (MDR) and in vitro Diagnostic Medical Devices (IVDR) to facilitate collaboration and cooperation within the medical devices network during the implementation phase of the new regulations.
The objective is to implement an effective, robust, predictable and secure regulatory system and ensuring better protection for public health in the medical devices sector. The taskforce is not intended to replace or prevent any national-specific implementation planning or activity that a competent authority wishes to conduct.
Following a decision at the May 2017 CAMD meeting in London, an additional group was established – the Transition Subgroup – with the remit of providing clarity on the transition provisions of the MDR and IVDR.
MDR/IVDR Transition Subgroup
The MDR/IVDR Transition Subgroup has developed some FAQs to provide clarity.
The key objectives of the Transition Subgroup are to:
- identify areas with the potential for inconsistent application;
- troubleshoot issues and provide recommendations or clarity, in the form of a ‘questions and answers’ document, on interpretation;
- where appropriate, seek legal input to underpin proposals;
- where appropriate, recommend the development of procedures to ensure authorities implement in a consistent manner.
I - Issue: Transition in general
II - Issue: Placing on the market of MDR compliant devices until 26 May 2020 (Art. 120 para 5-7 MDR)
III - Issue: Placing on the market of devices in conformity with the Directives after 26 May 2020 (Art. 120 para 2 -3 MDR)
IV - Issue: The so called “sell off” provision of Art. 120 para 4 MDR
V – Issue: EUDAMED and its relevance for the application of certain provisions of the MDR (Art. 123 para 3 d and e, Art. 120 para 8, Art. 122 MDR)
- AIMDD/MDD compliant device = device that is compliant with Directive 90/385/EEC/ Directive 93/42/EEC
- AIMDD/MDD certificates = certificates in accordance with Directive 90/385/EEC/ Directive 93/42/EEC
- DoA = date of application of the MDR
- MDR = Medical Device Regulation (EU) 2017/745
- MDR compliant device = device that is compliant with the MDR
- MDCG = Medical Device Coordination Group
- MFR = manufacturer
- PRRC = person responsible for regulatory compliance
- NB = notified body
- “old” NB = NB that has issued an AIMDD/MDD certificate
- The Directives = Directives 90/385/EEC, 93/42/EEC