Medical Devices, is your brand and company at risk?
Now, more than ever, it is important to check and ensure medical device conformity with the applicable regulations and to be confident that you have met all the requirements.
GB has taken a different regulatory pathway from the EU device regulations, so due consideration must be paid to the requirements of both the UK MDR 2002 as well as the EU Device Regulations, where applicable. The regulatory landscape is complex, and some organisations are not yet up to speed and it is not uncommon for others to get this wrong. Such misunderstanding or mistakes can be costly and can also damage the reputation of the company as well as the brand. The risk further increased with the MHRA’s new powers under the new Medicines and Medical Devices Act 2021 (The MMD Act _ February 2021).
It is also vital to understand the correct and applicable classification rule, in each territory. There are many cases where Class I (self-declared) devices are being up classed in the EU and such devices now require the involvement of an EU Notified Body. It is also the case that some National Competent Authorities may ask for evidence and challenge your devices, where others may not. A very recent example of this can be seen in Spain. The Spanish Agency of Medicines and Medical Devices (Competent Authority) have asked Nasus Pharma to recall and stop marketing Taffix Nasal Spray. It is the opinion of AEMPS that Taffix Nasal Spray should be classified as a Medical Device Class III (highest risk) and not Class I. The spray had made claims of protection from a wide range of allergens and viruses, including Sars-COV-2. There is some doubt over the clinical evidence available to support all claims being made.
All device Legal Manufacturers, no matter which territory, should ensure that they hold robust and supportive clinical evidence to underpin the commercial claims being made for the product.
If you would like guidance on these aspects or any other device or borderline matter, our technical and regulatory experts are available and ready to help you.
- Medical Devices, is your brand and company at risk? - March 23, 2021
- NHSX have just released their new Digital Technology Assessment Criteria for Health and Social Care (DTAC) - February 26, 2021
- Medical Device News (UK) - February 12, 2021