Preparation for the new regulations
The global disruption caused by the pandemic meant regulatory plans for 2020 needed to be delayed to give the life sciences industry and authorities breathing room. However, it is important to keep up to date with imminent regulatory changes that will impact the industry. In my last blog in this series (Getting Ready for the Clinical Trial Regulation) I discussed some key things to look out for now that the Clinical Trials Regulation implementation has been confirmed for December 2021.
“The implications of not being ready are severe: loss of CE mark certification”
May 2021 – Are you ready?
This year, key regulations such as the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) are back on the agenda. As of May 2021, medical devices companies will need to ensure they are ready to meet the regulation. The implications of not being ready are severe: loss of CE mark certification.
The MDR and IVDR bring medical devices more closely in line with medicinal product regulations in terms of clinical efficacy, vigilance and product oversight – whether that’s an implant, a surgical device that is sterilised and reused or a complex piece of machinery such as an MRI. For companies, that means having good quality management to ensure requirements are met.
Finding the correct Notified Body
One of the biggest challenges will be finding a notified body, since many have withdrawn their services in the re-qualification process, and those qualified and able to operate under MDR and IVDR have limited capacity. Potentially, companies that have not yet identified a notified body or started conversations with them could struggle to get their CE certification updated and approved in time.
Finding relevant regulatory expertise
Another challenge will be finding enough people with regulatory experience in medical devices. Given the likely shortage, companies will need to start training their staff on these new regulations, rather than relying on recruiting the right people.
MDR Impact Assessment and Actions
I would hope that all companies have started their impact assessments by now since these could be very time-consuming, involving several years-worth of toxicology reports and clinical investigations as well as looking into the real-world data.
Inevitably, there will be some products that are not worth the work involved for the manufacturer and these will likely be lost to the market. There are pros and cons to this. If the product can’t meet the standards required, it’s likely they shouldn’t be on the market; on the other hand, if products are lost to the market, how will that affect supply and demand and the broader needs of the healthcare system?
The pandemic gave companies a breather, but there is no time left to lose to prepare for the MDR. Companies would be wise to ensure they have the support they need to meet the tougher new requirements or seek help from experienced regulatory consultants.
To help you stay abreast of such regulatory changes our Regulatory On-Call service provides personalised responses to your ad hoc regulatory enquiries by way of a monthly retainer, get in touch for more information. Also look out for the other blogs in this series relating to General Data Protection Regulations and MHRA guidance on Orphan Drugs; work programmes that have not gone away but may have drifted from focus in the current environment.