European Regulatory Roundup: Notified Body Group Finds 45% Will Not Apply for IVDR Status

Posted 22 February 2018 | By Nick Paul Taylor 

European Regulatory Roundup: Notified Body Group Finds 45% Will Not Apply for IVDR Status

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Warns Pharma Will Step up Contingency Plans Unless Brexit Transition Agreed Soon
A parliamentary committee has warned the British government it must provide clarity on the Brexit transition by next month or risk pharma businesses accelerating their contingency plans. The health committee thinks continued uncertainty will force companies to take precautionary steps, driving up their costs and potentially reducing their presence in the United Kingdom.
British and European negotiators have both expressed an interest in agreeing to a transition period that maintains something like the status quo for a set amount of time. That would give governments and companies more time to prepare for the UK’s more decisive split from the European Union and show how the long-term business and regulatory environments will look. However, the openness to the idea of a transition period is yet to manifest in an agreement.
At first glance it looks like there is considerable time to finalize transition terms, which will only come into play after the UK leaves the EU at the end of March 2019. Yet, this overlooks the pressures faced by companies. There remains a risk the UK will become a third country in the eyes of the European Medicines Agency (EMA) next year. Until that risk is extinguished with a transition deal, companies need to prepare for the worst.
Companies have been taking contingency steps for some time, but, having spoken to the industry, the health committee thinks the UK is nearing a tipping point. Contingency planning will accelerate if the UK fails to provide clarity in the next six weeks.
“If the announcement, and details, of a transition period is delayed beyond March 2018, more businesses will be forced to invest money in contingency plans at the expense of this funding going towards advancing patient care. This is an unnecessary cost and distraction, which should be avoided,” Sarah Wollaston, chair of the health committee, wrote. Wollaston made the comments in a letter to Health Secretary Jeremy Hunt.
The health committee chair went on to advise Hunt about steps the government should take in the event it cannot agree transition terms soon. In that event, Wollaston wants the government and EU to issue a joint statement setting out how they will insulate patients from the fallout of a no-deal exit. Failing that, Wollaston wants the UK to unilaterally release details of its preparations for a no-deal situation. 
Committee Letter
Notified Body Group Finds 45% of Members Will Not Apply for IVDR Status
Almost half of the notified bodies in Team-NB have no plans to be designated against the In Vitro Diagnostics Regulation (IVDR). The survey data validate anecdotal reports that a limited number of organizations will be available to handle the anticipated uptick in work in the coming years.
Under the incoming regulatory framework, many IVDs will require the oversight of notified bodies for the first time. Notified bodies need to get designated to perform this week. Team-NB, also known as The European Association for Medical devices of Notified Bodies, shared data from a survey of its members that provide an insight into how preparations for the regulatory change are going.
Team-NB found 11 of its members plan to get designated against IVDR. That is about half the number that are applying for Medical Device Regulation (MDR) status. Eight of the notified bodies filed their IVDR applications last year. The other three will do so in 2018. The notified body designation process typically takes about 18 months.
That means a small cadre of notified bodies should become equipped for IVD certification part way through the regulatory transition period. Whether they will have the capacity to handle demand is an open question, though. Data from MedTech Europe suggests that if 11 organizations get IVDR status, each notified body will need to handle 3,200 IVDs. That figure is many times their current workload.
While that suggests the regulatory transition may be problematic, the picture is somewhat brighter than previous reports suggested. In September, the Medical Devices Legal blog quoted a representative of one notified body as saying only five organizations were expected to seek IVDR designation.
Survey Data, Medical Devices Legal
Ireland Posts Guide for Distributors of Medical Devices in the MDR Era
The Health Products Regulatory Authority (HPRA) of Ireland has published a guide for distributors of medical devices. In the text, HPRA explains how distributors can meet obligations tied to incoming European medical device and in-vitro diagnostic regulations.
Distributors have until 2020 to meet the obligations imposed by the medical device regulation and a further two years to bring their operations in line with the IVD requirements. Yet, with MDR and IVDR representing significant changes to the European device industry, HPRA wants to ensure distributors use all the available time to adapt their practices to the incoming requirements.
The 29-page guide released by HPRA outlines what this will entail. HPRA’s text starts by highlighting the sections of the incoming legislation that apply to distributors, before discussing how the rules will affect the industry.
HPRA dedicates a substantial portion of the guide to the implementation of quality systems. The Irish agency sees the establishment of quality systems as a way for distributors to ensure they meet their obligations and only make compliant devices available for supply. HPRA expects management to be involved in the creation of the system and to ensure the initiative is adequately resourced. The quality system section also covers change control, risk management and complaints.
Irish officials also dedicate a significant share of the guide to the receipt, storage and supply of medical devices. The prominence of the section reflects HPRA’s belief distributors need to establish robust systems for approving new suppliers to minimize the risk of falsified medical devices entering the supply chain. MDR and IVDR put the onus on distributors for ensuring devices are CE marked and otherwise compliant before they are placed on the market.
HPRA Guide
France Shares Q&A for Researchers Working with Microorganisms and Toxins
The French drug regulator has explained how researchers working with microorganisms and toxins can comply with regulations. Officials used the question and answer document to outline when people need pre-authorization and what that entails.
French regulations require companies that want to work with ricin and certain other toxins to gain regulatory clearance before starting to operate. The Q&A details the paperwork organizations need to complete to gain clearance to work with the substances.  
The document also covers how long it typically takes to receive authorization, how long the clearance is valid for and how the regulations apply to researchers who manipulate the genetics of microorganisms. 
ANSM Q&A (French)
Other News:
The Danish Medicines Agency (DKMA) has stopped sending physical letters about marketing authorizations to local companies. DKMA had already switched to encrypted digital mail to communicate news of marketing authorization decisions to Danish companies. Foreign businesses will continue to receive physical letters regarding their marketing authorizations. DKMA Note (Danish)
EMA has released the agenda for its upcoming meeting to discuss the effect of Brexit on veterinary medicine companies. The centerpieces of the half-day event are presentations about the impact of the UK’s split from the EU on veterinary applications and on manufacturing, supply and compliance. The agenda includes a 45-minute question and answer session. EMA Agenda

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