A scientific investigation will not be obligatory for Implantable and Class III medical gadgets below Article 61(4)-(6) of the European Union Medical Machine Regulation (EU MDR) if certainly one of 4 instances apply to the system below analysis, stated John Thomas, director of program supply of MedTech at Premier Research.
With the EU MDR turning into totally relevant to all medical gadgets in Europe from 27 Might, the brand new laws have been on the centre of talks on the Outsourcing in Clinical Trials: Medical Devices Europe 2024 conference in Munich, Germany on 30-31 January.
Thomas detailed the 4 instances the place a scientific investigation just isn’t mandated for Class III and implantable gadgets below the EU MDR. First, is the case the place the system below analysis is a ‘design modification’ of a tool already marketed by the identical producer. On this occasion, equivalence must be demonstrated in compliance with the MDR Annex XIV Part 3 and be endorsed by a notified physique (NB).
Right here, a scientific analysis is adequate to reveal the conformity of the modified system with the related common security and efficiency necessities (GSPRs). Though scientific investigation just isn’t obligatory on this case, a post-market scientific follow-up (PMCF) research is required to reveal the protection and efficiency of the system, stated Thomas.
One other occasion the place a producer just isn’t mandated to conduct a scientific investigation is that if it has a contract with one other producer with an equal system and the partnership permits the previous full entry to the technical documentation to determine equivalence with the marketed system, the place equivalence is demonstrated compliant with MDR Annex VIX part 3 and endorsed by a NB and the scientific information from the equal system is adequate to assist the meant goal of the ‘Machine Underneath Analysis’. Right here, as within the earlier occasion, a PMCF research is required to reveal the protection and efficiency of the system.
Medical system producers can be exempted from mandated scientific investigations both their system has been lawfully positioned available on the market, or put into service below directives 90/385 or 93/42/EEC. The system producers may also escape the mandated scientific investigations ought to their system be listed on the well-established expertise (WET) listing in Article 61(6)(b) of the EU MDR.
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Thomas added that if not one of the 4 instances below Article 61(4)-(6) EU MDR are relevant, a scientific investigation(s) is obligatory for implantable and Class III gadgets. A guidance document on the problem has been revealed by the Medical Machine Coordination Group (MDCG) in December 2023.
Thomas closed by including producers ought to ask themselves, what will be carried out by their very own assets, and what might should be supported by partnering group, which has scientific product improvement capabilities and may handle regulatory compliance, be suitably certified with material experience who can provide programs and processes to convey options to any challenges of any stage of the system lifecycle.