Euro Roundup: Switzerland joins EU in bringing in new IVD requirements to improve patient safety

RoundupsRoundups | 02 June 2022 |  By 

The new ordinance on In vitro Diagnostic Medical Devices (IvDO) has come into force in Switzerland, bringing in stricter requirements for conformity assessment and post-market surveillance in an aim to improve patient safety.
 
Switzerland brought IvDO into force on 26 May, the same day as the In Vitro Diagnostic Regulation (IVDR) took effect across the border in the European Union. When Switzerland began work on IvDO, it enjoyed barrier-free mutual market access with the EU as part of an arrangement dating back to 2001 that gave it equivalent medical device regulations. However, the failure to update a mutual recognition agreement (MRA) complicated the situation between IvDO being drafted and coming into force.
 
“In the absence of this updating, the same ‘third country rules’ that have applied to other medical devices for a year will now also apply to in vitro diagnostic medical devices,” the Swiss Agency for Therapeutic Products (Swissmedic) wrote in a statement to disclose the start of IvDO.
 
Switzerland has taken the transitional periods now in place in the EU, which will stagger IVDR out to 2027, into account in IvDO. As Swissmedic explained, “IvDO additionally stipulates various transitional periods and measures designed to ensure that Switzerland continues to be supplied with safe in vitro diagnostic medical devices and to limit the negative consequences of failure to update the MRA on surveillance.”
 
The additional Swiss stipulations include provisions allowing the unilateral recognition of EU certificates of conformity with the goal of reducing IVD supply problems. Swissmedic is looking to supplementary requirements such as the registration of economic operators, the reporting of serious incidents and the establishment of Swiss authorized representatives for foreign manufacturers to maintain surveillance despite being cut off from the network of EU authorities.
 
Foreign manufacturers of most IVDs have more than one year to designate their Swiss authorized representatives, known by the abbreviation CH-REP. The transition time is intended to help maintain the supply of IVDs. Switzerland has also adopted transitional provisions for obligations related to registration and reporting. Manufacturers of IVDs intended for use by healthcare professionals may provide details of the CH-REP on a document accompanying the device until 31 March 2025.
 
Because Swiss manufacturers, importers and authorized representatives lack access to the European EUDAMED3 database, they must register with Swissmedic and obtain a Swiss Single Registration Number. The registration process for medical devices began one year ago.
 
Now that IvDO has taken effect, Swissmedic will be replacing documents relating to the old law on its website. “Changes and newly available documents will be added continuously. Because very many documents are affected, and in view of the short period of three weeks between adoption and entry into force of the new legal requirements, delays may occur in individual cases,” Swissmedic wrote.
 
Swissmedic Notice, More
 
MHRA acts to cut risks of Roche Accu-Chek Insight Insulin Pumps after fault reports
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has taken safety action to reduce risks associated with Roche Accu-Chek Insight Insulin Pumps. MHRA issued a national safety alert and recommendations for patients after learning about cracked cartridges and insulin leaks.
 
In light of the potential problems, MHRA has asked patients to check the pre-filled glass insulin cartridge for cracks prior to use and warned against using dropped cartridges even if no cracks are visible. MHRA is also advising patients to closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin cartridges.
 
Patients should check their pumps are delivering insulin during the day and before going to sleep and check their blood glucose levels multiple times a day. The failure of the device to deliver insulin may not trigger an alert, and not all leaks are visible, according to MHRA. 
 
The recommendations are intended to mitigate the problems seen in reported leakage incidents. Some of the leaks involved cracked cartridges that provided an inadequate supply of insulin to patients. Yet, the agency has also learned of leaks that happened despite the absence of visible cracks in the cartridge. Some patients suffered severely high blood sugar and diabetic ketoacidosis, a serious complication of diabetes, because their pump systems failed to provide enough insulin.
 
Roche has implemented risk minimization strategies but, according to MHRA, their impact is inconclusive. The agency said the rate of leak reports has fallen since the implementation of a revised adapter and tubing design in September but the risk, while low, remains.
 
“We would like to reassure patients that risk of leakage remains low when used in accordance with instructions and today’s safety recommendations. Patients should continue to use their insulin pump as recommended whilst they await contact from their healthcare professional regarding an alternative device,” June Raine, chief executive at MHRA, said.
 
MHRA has asked healthcare professionals to contact patients over the next six months.
 
MHRA Notice, More
 
Ireland’s HPRA seeks feedback on draft advice about Clinical Trial Regulation
 
Ireland’s Health Products Regulatory Authority (HPRA) is seeking feedback on its approach to an aspect of the Clinical Trial Regulation (CTR) that allows certain preparation, relabeling and repackaging steps to happen at sites that do not hold a manufacturer’s authorization.
 
CTR’s Register of Exemptions allows the processes to take place in a hospital, health center or clinic participating in the trial without a manufacturer’s authorization. To help stakeholders understand the rule, HPRA has created a draft question and answer document that is now open for comment.
 
The 18-question document explains that hospitals, health centers and clinics can carry out the processes on behalf of other Irish sites participating in the same clinical trial, and that from 31 January 2023 processes relating to investigational products conducted under CTR should be registered before the work starts. Registration is not required for the reconstitution processes for investigational products if they fulfill the conditions in the European Commission’s guidelines on the topic.
 
Other responses explain that the blinding of an investigational product must be carried out by the holder of a manufacturer’s authorization and that hospitals, health centers and clinics cannot import products from third countries for use in a clinical trial.
 
HPRA is accepting feedback until 22 August.
 
Consultation Document
 
EMA appoints Thirstrup as chief medical officer to reinforce public health response
 
The European Medicines Agency (EMA) has appointed Steffen Thirstrup as its chief medical officer. The role positions Thirstrup to provide scientific leadership to reinforce EMA’s capacity to respond to public health challenges and emergencies.
 
Thirstrup spent the past nine years as a director at NDA Advisory Services, a regulatory drug and device development consultancy. Prior to that, Thirstrup worked at the Danish Medicines Agency, where he held roles including chief medical officer and head of the Institute of Rational Pharmacotherapy. Thirstrup is a medical doctor with a PhD in pharmacology.
 
EMA expects its new hire to be its “medical voice” with external stakeholders and explain the factors that define its decisions about the risks and benefits of medicinal products. The agency also sees Thirstrup shaping its contribution to EU-level health initiatives such as Europe’s Beating Cancer Plan and the work to counter antimicrobial resistance.
 
EMA Notice
 
Other News:
 
Swissmedic has begun reviewing an application to provide Pfizer’s COVID-19 vaccine as a booster to children aged five to 11 years. Swissmedic Notice

 

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