GAMBICA | Lab Brief - November 2024

Lab Brief - November 2024

Good sense in the UK – and some of the same in the EU

Hello again,

According to Invest 2035, which sets out how government intends to deliver growth: ‘Over the next decade, the life sciences sector holds enormous potential to drive economic growth and productivity. It is built on over 6,800 businesses that generated over £100 billion in turnover(2021 to 2022 figures). The UK is also home to 4 of the top 10 global universities for life sciences and medicine, and with the expertise of the NHS, the UK is a global hub for innovation’.

So that’s all good, but threats to UK success in life sciences have come in the shape of the European Parliament's rapid revision of the MDR/IVDR regulations requiring the re-certification of tens if not hundreds of thousands of products.

A recent German-inspired resolution from the European Parliament has called on the EU Commission to act by the end of the first quarter of 2025 to relieve the burden on medical technology companies which have suffered from the bureaucratic and lengthy certification processes.

The resolution demands:

The simplification and acceleration of certification procedures and the introduction of transparent and binding deadlines.
The elimination of unnecessary recertifications and the reduction of administrative burdens, especially for SMEs.
The creation of fast-track procedures for innovative products and products that address undermet medical needs.
The full implementation of the European product database EUDAMED to create more transparency.
Clear regulations for medical devices for rare diseases and increased support for SMEs, for example through guidelines and model forms.

Meanwhile, in the UK a consultation is underway to introduce ‘International reliance’ a mechanism through which some medical devices could access the GB market more quickly if they have already been approved by a comparable regulator in another country which seems a sensible step to avoiding doubling the compliance costs of UK manufacturers. It is also looking at keeping some EU law in force to help smooth out some of the bumps.

Thank goodness – some sense at last!

Toodle pip!

Jacqueline

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