As announced by the British Medicines and Healthcare products Regulatory Agency (MHRA) on 22 July, the United Kingdom will take various steps to simplify the market authorisation of medical devices.
An Overview of the Changes
The MHRA explicitly annouced four steps:
- In future, so-called international recognition procedures (‘international reliance routes’) are to be introduced. These will enable certain medical devices that have already been approved by authorities such as the TGA (Australia), HealthCanada or the FDA (USA), will be able to use a simplified approval process for the British market. Medical software and implantable devices in particular are expected to benefit from this innovation.
- The British government also plans to permanently recognise CE-marked medical devices before the end of this year. Currently, such products may continue to be placed on the British market under existing transitional arrangements – depending on their risk class, either until 30 June 2028 or 2030.
- Once the introduction of the Unique Device Identification (UDI) has been completed, the physical UKCA marking on the product will also be discontinued. The aim of this measure is to simplify the regulatory requirements for manufacturers through harmonisation with EU law and, at the same time improve traceability and post-market surveillance practices.
- For Class B in vitro diagnostic medical devices (IVD), the MHRA wants to implement a ‘more risk-appropriate’ approach. Manufacturers will be allowed to declare conformity with the UK Medical Devices Regulation from 2002 in their own responsibility, but must have a certified quality management system in accordance with ISO 13485 before placing the devices on the UK market.
Consequences for Manufacturers and Importers in the UK
The new regulations offer opportunities for manufacturers: simplified approval procedures eliminate bureaucratic effort, costs for applications and legal proceedings, and free up time. This allows manufacturers and importers to focus better on their core business.
The simplification of the approval process represents a significant relief for smaller manufacturers in particular, as they often struggle with the high costs of complex regulatory requirements.
However, the MHRA announcement also shows that many of these changes are still in the planning stage and have not yet been translated into law. This means that the signs point to simplification, but it remains to be seen when and how exactly the MHRA will implement its announcements.
Despite simplified accreditation procedures, compliance with regulatory requirements remains a challenging process – it is being shortened, but not made significantly easier.
Another, less proclaimed consequence of the measures is, of course, that they will also ease the burden on the British state apparatus – because less scrutiny on the part of the government means less work for bureaucrats – a side effect in line with other neoliberal or New Public Management measures recently adopted by the MHRA..
This step also gives authorities such as the FDA, Health Canada and the Australian TGA more power to define the criteria for a compliant medical device – ultimately, the MHRA is relinquishing some of its legislative responsibility.
However, one thing is certain for BEO BERLIN: regardless of the regulatory future in the EU and the UK, we are there for our clients. We consult, create and coordinate QM systems and technical documentations for you, or take on the role of a person responsibly for regulatory compliance (PRRC) for your company. Professional, pragmatic and, above all, partnership-based.
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