Regulatory
down what all parties hope will be rapid parallel approval processes. Coordinating post-market surveillance and sharing safety data across multiple jurisdictions can be challenging, which raises concerns about safety monitoring, and communication gaps leave room for risk or process disruption. Regulatory bodies may have different expectations regarding the amount of clinical data needed, which can create challenges for manufacturers. In some cases, studies have suggested that regulatory differences can contribute to what researchers call a ‘medical device lag’, delaying patient access to cutting-edge medical devices and reducing competitiveness. This is particularly felt by manufacturers in the form of high costs and the complexity of navigating regulatory frameworks, even when there is some harmonisation or bilateral agreement.
The road to recognition
Broader international recognition and reliance frameworks are opening faster and more flexible avenues for medical device manufacturers to bring their products to new markets. They aim to compress approval timelines and do away with unnecessary duplication in the approval process. Whereas MRAs establish a relationship between two countries and rest on reciprocity, with both sides recognising each other’s processes equally with full recognition of conformity assessments across a wide range of devices, recognition and reliance agreements see a single jurisdiction directly accept the approval process of a trusted foreign regulator. Under its proposed international recognition framework, the MHRA plans to rely on certain approvals or certificates from trusted regulators such as the US FDA or Health Canada to streamline, rather than duplicate, its own UK review. A regulator such as the MHRA relies upon and uses the assessment reports and decisions of another trusted regulator to speed up its own review process. Unlike traditional bilateral MRAs, these recognition routes can be unilateral, with the UK relying on FDA processes, for example, without a strict requirement for reciprocal recognition by the partner regulator. The result is a more flexible arrangement that can often move faster towards implementation than a full MRA. The UK’s MHRA is in the process of implementing new international recognition routes for medical devices, based on reliance on approvals from comparable regulator countries, with reliance routes expected to become operational from 2027. Voluntary programmes like the Medical Device Single Audit Program (MDSAP) have already formalised collaborative, multi-country recognition of quality management systems in recent years. Trust, speed and collaboration across borders are what the MHRA seeks, as it aims to help the UK
www.medicaldevice-developments.com
IMDRF ‘Table of Contents’ (ToC) Format
Ever tried to read a regulatory submission that feels like a 500-page scavenger hunt? That’s exactly the kind of problem the International Medical Device Regulators Forum (IMDRF) set out to fix with its Table of Contents (ToC) format. In simple terms, the ToC is a standard way to organise medical device regulatory submissions. Instead of every company structuring its technical documentation differently, the IMDRF format lays out a shared framework so regulators know where to find things and manufacturers know where to put them. The format breaks a submission into a clear set of sections and sub-sections. Think device description, design and manufacturing information, risk management, verification and validation testing, clinical evidence, labelling – the whole story of the device but arranged in a predictable way. That structure makes it far easier for regulators to navigate a dossier without digging through unrelated material. For manufacturers, there’s another practical benefit: reuse. Once you’ve built your technical documentation in the ToC structure, much of it can be reused across different regulatory submissions. Anyone who’s prepared filings for multiple countries knows how valuable that can be. Less reinventing the wheel, fewer late-night document rewrites. The ToC format sits within a broader IMDRF push to bring regulators closer together and make information exchange smoother. Around the same time, the forum also developed the Medical Device Single Audit Program (MDSAP), which allows a single quality system audit to be recognised by several regulatory authorities. Put simply, the idea is to create a common architecture for regulatory dossiers. When submissions follow the same structure, reviews can become more efficient, duplication drops, and everyone – regulators and manufacturers alike – can focus on what actually matters: whether the device is safe and performs as intended. Authorities in the US, Canada, Japan and Australia participate in IMDRF initiatives related to the ToC framework, and other jurisdictions may adopt or adapt it depending on their own regulatory systems. Not every region applies it in the same way, but the direction
of travel is clear: more consistency, less paperwork chaos. Source: Assembly and Technical Guide for IMDRF Table of Contents Submissions
towards its goal of becoming a global leader in life sciences. It is trying to not only improve access to medical devices for NHS patients but also promote the UK as a friendly environment for life sciences companies. The introduction of new international recognition routes for medicines and medical devices is a key pillar of that strategy. It is aiming to streamline medical approvals while maintaining high standards, and it is initially working with trusted regulators such as the FDA and counterparts in Australia, Canada the EU, Japan, Singapore and Switzerland. It is opening the possibility of fast-tracking approvals for products that have already achieved authorisation by selected overseas regulators, reducing the need to duplicate work that has already been done to assess these devices.
For medical devices the key routes will be for devices approved or certified under the frameworks of Australia’s Therapeutic Goods Administration (TGA), Health Canada, the EU’s CE marking system and the FDA, with Japan under consideration for future inclusion as a comparable regulator country. For medicines, approvals from seven international partners will be recognised. For medical device companies, the message is clear – start preparing now. This preparation may involve reviewing existing approvals and aligning documentation with MHRA requirements. That will position them to achieve streamlined entry into the UK and significantly reduce time- to-market.
13
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100
