Laia París Coderch, PhD – Medical Devices (& In Vitro) Regulatory and Quality Consultant, Rephine
At a quickening pace now, the regulations and quality/safety controls around medical devices (MD) and in vitro medical devices (IVD) are being brought in line with those for pharmaceutical products. That’s in the wake of high-profile safety issues over the last decade or more, which shone a light on the need for improved controls by manufacturers and tracking capabilities for National Competent Authorities and market regulators.
Specifically, they have given rise to the need for a more robust, transparent and homogenic regulatory framework for medical devices in Europe – in the form of the Regulation (EU) 2017/745 Medical Device Regulation (MDR) and the in vitro equivalent Regulation (EU) 2017/746 (IVDR). These were published in 2017, in the case of MDR coming into force two years ago (after a year’s delay due to the COVID-19 pandemic); followed by IVDR a year later.
These Regulations are now fully applicable, both for all new devices being developed, and for legacy devices – defined as MDs and IVDs covered by a valid certificate issued in accordance with former Directives, which will continue to be on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR). To this end, the Regulations allow a number of transitional provisions, in that legacy devices manufacturers will be allowed extra time to commercialise according to the Directive’s certificate – as long as they apply for or can demonstrate compliance with at least some of the new regulatory requirements.
At a general level, the transition from EU Directives to Regulations, designed to provide aligned and homogenic market access rules across Europe, has brought with it a broadening in scope in its application, as the definition of “medical device” has been expanded. There are new, clear obligations for all economic operators, too – not just manufacturers but also Notified Bodies and Competent Authorities – and an elevated and more complex risk classification and conformity assessment rules have been introduced.
Regulations provide extended general safety and performance requirements (GSPR) and new clinical evidence requirements that need to be considered for conformity assessment. In particular, there is a strong emphasis on the management of the device across its lifecycle, with a view to tracing products and controlling the risk from the design to post-market phase, until device expiry or withdrawal.
Developing an action plan
So, what, then, should legacy manufacturers be doing to stay compliant?
The first task is to review the definition of what now constitutes a medical device under the broader scope of the MDR and IVDR regulations.
The next consideration, for any affected device, is the requirement for a unique device identification (UDI) attached to a device and/or its packaging. This is a numeric code used to enhance traceability across the European market, to enhance the effectiveness of the post-market surveillance and vigilance activities – to reduce medical errors, fight against device falsification and improve stock management.
Another new obligation for device manufacturers is that they must now designate a Person Responsible for Regulatory Compliance (PRRC) within their organisation – someone highly qualified, with extensive experience in quality, or regulatory affairs relating to MDs and/or IVDs – small companies could outsource this role, if needed. PRRC responsibilities include ensuring that a device is appropriately checked before release, guaranteeing compliance with the regulations and the quality management system (QMS) of the manufacturer; ensuring that the declaration of conformity and technical documentation are up to date and accurate, and that procedures for post-market surveillance and vigilance are in place.
From the day of application of the Regulations, manufacturers should classify their devices according to the enhanced risk classification rules. For the majority, the new rules will entail a risk-class increase, meaning that conformity assessment will involve scrutiny and evaluation from a team of inspectors, named as Notified Bodies.
Fulfilling the conformity assessment is likely to necessitate a revision of QMS, now under the scope of MDR and IVDR, as well as an evaluation of the technical documentation – with additional clinical performance procedures or requirements, and post-market surveillance requirements, according to the risk class of the device (requirements increasing with the perceived risk).
Transparency and coordination between member states is also amended in the Regulations, as device manufacturers must demonstrate compliance via the European Database on Medical Devices (EUDAMED), a centralised IT system developed by the European Commission. Several restricted modules are included for the registration of economic operators, Notified Bodies, devices and UDI, and for the uploading of certain documents and records – especially certificates and details of any clinical investigations, vigilance events and market surveillance activities. It is worth noting that EUDAMED is due to be accompanied by a public web site that will ease information access for health professionals and the general public. EUDAMED is expected to be fully applicable by Q4, 2024.
How we can help
Rephine’s experts are fully au fait with the latest requirements and timelines, and are on hand to help with any advice or support as manufacturers adapt their activities and provisions in the light of the evolving regulatory expectations.
Here are just some of the specific ways we can help:
- If you’re a manufacturer planning to place your device into the European market, our Medical Device Quality and Regulatory Consultancy Team can help with designing a tailored regulatory roadmap strategy and assessing the risk classification of your device.
- If you already have legacy devices on the EU market, or want to check your compliance readiness, we can perform a gap assessment of your technical documentation and help you to complete it to meet the latest requirements.
- We can also help you improve your MD and IVD Quality Management System to bring it in line with MDR/IVDR compliance, and/or to support EN ISO 13485 certification. This includes adaptation and enhancement of your risk assessment procedures by applying EN ISO 13485 and EN ISO 14971 requirements for MD and IVD.
- We can act as a Person Responsible for Regulatory Compliance for micro and small companies.
- If you are outside of Europe, we can serve as your Authorised Representative in EU markets.
- Finally, we can also help with performing internal audits or auditing your critical suppliers.
To find out more about our services, or to discuss a specific requirement, get in touch with our Medical Devices expert.