New Regulatory Requirements for IVF Device Manufacturers

The European In Vitro Device Regulation (IVDR) should ultimately be a great leap forward for the industry, however, most IVF device manufacturers still have a lot to do to ensure a smooth transition.

Things have come a long way since British physiologist Robert Edwards and gynaecologist Patrick Steptoe gave us in vitro fertilisation – a ground-breaking technique which would bring joy to millions of infertile couples around the world. Louise Brown, the first “test tube baby”, was born at Oldham General Hospital in Lancashire on 25 July 1978, a monumental scientific triumph that spawned a global in vitro fertilisation industry, a powerhouse of innovation and scientific excellence and a huge source of income for many actors in the value chain.

However, what was once a self-regulated industry is becoming subject to increasingly stringent requirements for clinical evidence demonstrating conformity, post-market performance and traceability in a market that spans nations and continents. And within the next few months, another enormous change is set to take place. The countdown to the long-awaited European In Vitro Device Regulation is almost over. The new regulation covers everything from laboratory-developed tests, point of care devices, instruments, reagents, to kits used to analyse human samples and guide clinical decision making. Have you been putting things off? The clock is ticking. But if your company is not yet IVDR-ready, don’t panic! CPSL has a dedicated team that tracks developments in the medical device field and highly qualified experts to help medical and healthcare companies to comply with this major regulatory overhaul that calls for reclassification and recertification of all IVD devices registered in the European Union.

“While there is undoubtedly a huge amount of work required to transition from the IVDD to the IVDR, manufacturers should recognise the IVDR is more complex and detailed and will require more resources to maintain as well as implement.” Sue Spencer,  consultant, Regulatory Affairs Professionals Society (RAPS).

The IVDR will mean making significant changes to technical documentation and quality management systems, all of which will have a far-reaching impact on the entire supply chain. A great deal of this new documentation will need to be perfectly translated into several languages, which is a daunting task for companies that know everything about manufacturing equipment for in vitro fertilisation, egg donation and vitrification, artificial insemination, pre-implantation genetic screening but know nothing about translation, an area where CPSL has extensive experience.

When translating these types of documents, CPSL uses computer-assisted translation programs combined with glossaries to ensure that the terminology used in your documents is consistent and accurate, with the added advantage that this also keeps costs down. Contact our team for more information about how we can take care of your language tasks during the countdown to full implementation.

IVF Tourism

IVF is a truly international affair. Website “Destination Fertility” has just published a list of the top ten countries to visit for these treatments, and Spain, with its excellent healthcare system, modern facilities and highly trained specialised physicians is a favourite destination for fertility tourists. Spain is particularly popular because anyone can be treated, regardless of age, marital status, and sexual orientation, thanks to non-discrimination laws in the healthcare field, unlike other countries, such as Greece, where non-heterosexual couples are not afforded the same consideration. Interestingly, France came into line with several other European Countries on 20 June 2021 when the country’s parliament definitively approved a bill that will give same-sex couples and single women the right to access medically assisted fertility treatments.

This makes Spain a great market for exporters of IVF medical devices, for which, of course, the importer must have a health licence issued by the Spanish Agency for Medicines and Medical Devices (AEMPS). CPSL can provide your company with official and regular translations to streamline this and other formalities by guaranteeing rigorous, accurate work on which you can rely, saving you time, money, and headaches.

• European Manufacturers and the new Regulation.

Following pressure from the medical device industry and the EU member states, on 16 February 2023, the European Parliament voted to amend the transitional provisions in Regulation (EU) 2017/745 on medical devices (“MDR”) and Regulation (EU) 2017/745 on in Vitro Diagnostic Medical Devices (IVDR). Although the approved amendment did not introduce substantive revisions in terms of the quality, safety, and performance requirements established in the MDR and the IVDR, it has given medical device manufacturers additional time to ensure that their devices conform with those requirements, prolonging the validity of CE certificates of conformity issued in accordance with the MDD, AIMDD, and the In Vitro Medical Devices Directive 98/79/EEC (“IVDD”), before 26 May 2021. Those looking to obtain a CE Mark and market their products in Europe will find a fresh set of more stringent, thorough, and far-reaching considerations to adhere to. The regulation modernises and brings EU legislation up to date with medical advances to ensure better protection of public health and patient safety, with new features such as Unique Device Identifiers (UDI), the European Database on Medical Devices (EUDAMED), an implant card for patients and stricter control for high-risk devices. In fact, the creation of EUDAMED is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746).

EUDAMED will be a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g., manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.

EUDAMED will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance, and market surveillance.

Unlike Directives, Regulations do not need to be transposed into national law, so the IVDR will limit discrepancies in interpretation across the EU market. The EU is warning IVDR manufacturers of their responsibility to start the transition as soon as possible and ensure that their products are CE-Marked for the European Market under the new regulation. Although some provisions have been made in case more time is needed, it is still essential to act early due to the high number of devices on the market, the expected in reviews by notified bodies and the need to interpret several provisions.

• Beyond the EU. Post-Brexit changes and the IVF sector.

Now outside the single market, in the United Kingdom, the Human Fertilisation & Embryology Authority is supporting the sector with new regulatory requirements as a result of the country’s departure from the European Union. The Human Fertilisation and Embryology (Amendment) (EU Exit) Regulations 2019 provided for a six-month transitional period for the UK that ended on 30 June 2021. Now that transitional period is over, a new version of General Direction 0006 (GB) version 9 has taken effect, setting out the requirements imposed on clinics in the United Kingdom for imports and exports of gametes and embryos.

Although CE marking will continue to be recognised in Great Britain until 31 December 2024, and certificates will be issued by EU-recognised Notified bodies until this date, the EU will no longer recognise UK Notified Bodies, and they can no longer issue CE certificates.  Meanwhile, device manufacturers and suppliers in Great Britain must register with the MHRA and manufacturers not established in the UK must appoint a UK Responsible person to register and act on their behalf. CPSL can help to cut through the red tape by providing you with the official translations you will need to complete these new formalities.

• What about IVF in the United States?

In the United States, according to the American Society for Reproductive Medicine (ASRM) in its 2021 oversight report, in the US alone, infertility affects around 7.3 million women and their partners, or about 12% of the reproductive-aged population.

As with all medical practice in the US, safety in this area is regulated by a combination of state and federal government and professional regulations. On the state level, there is a strict physician licensure system, while on the federal level, assisted reproductive medicine falls within the purview of three agencies: the Centers for Disease Control and Prevention (CDC), which collects and publishes data, the Food and Drug Administration (FDA), which controls approval and use of drugs, biological products, and medical devices, and has jurisdiction over screening and testing of reproductive tissues, such as donor eggs and sperm. The third is the Centers for Medicare and Medicaid Services. Its work is combined with broad medical self-regulation. Manufacturers often launch in Europe before the US; therefore, US manufacturers should also be making moves to adapt their documentation and registrations to the upcoming requirements.

Whether you are a medical device manufacturer looking for a trusted language services provider to help you navigate the transition to the IVDR, an exporter or importer looking for technical documents and certificates or a hospital or clinic with a multilingual clientele, you can rely on CPSL to lighten the load.

Contact us for more information about these and our portfolio of services for the Medical and Pharmaceutical sectors.