On September 26th, 2012, the European Commission adopted a proposal for a regulation of the European Parliament and of the Council, to revise existing legislation on medical devices, amending directive 2001/83/EC (MDD), regulation (EC) No. 178/2002 and regulation (EC) No. 1223/2009. The objective, among other things: a high level of health and safety protection for European citizens using home-use items – like pregnancy tests and contact lenses – or professional equipment such as x-ray machines, breast implants or hip replacements. The proposal will be adopted alongside a proposal for a new regulation on in vitro diagnostic medical devices (IVDs), currently covered by directive 98/79/EC. When effective, these two regulations will replace the existing three medical devices directives.
‘Joining Forces in Corneal Regeneration Research’
For manufacturers of (active implantable) medical devices and in vitro diagnostic medical devices, it’s important to keep informed and updated on medical device legislation changes like the above. For that reason I was invited by the University Hospital of Antwerp to speak during a COST Action event on September 4th, 2015. COST Actions are bottom-up science and technology networks and form a flexible and efficient networking instrument for researchers, engineers and scholars to cooperate and coordinate nationally funded research activities. This time, the subject was ‘Joining Forces in Corneal Regeneration Research’ and the event took place during the EuCornea conference in Barcelona. This conference was all about linking researchers in the field of biomaterial research, stem cell manipulation, tissue engineering, ophthalmology and immunology to boost the development of biodegradable artificial corneas and to provide the foundation for a new generation of cornea specialists.
Upcoming changes in medical device legislation
Corneal blindness is a worldwide problem. There’s a wide variety of infectious eye diseases that cause corneal scarring, and in the end can lead to functional blindness. Fortunately, there is a treatment in the form of transplantation of donor human tissue, or by implantation of artificial, non-biological corneas. For people involved in these processes, but also in other operations regarding medical devices, legislation is something to keep an eye on. That’s why I gave the attendees an overview on current guidelines and directives related to medical devices, and an update on the upcoming changes in this field. For example, about the possible introduction of the requirement that a ‘qualified person’ within a manufacturer’s organisation should be responsible for regulatory compliance. Another important fact for the attendees is the proposal to streamline and tighten the different conformity assessment procedures that currently exist. During an assessment procedure, a notified body – i.e. an independent third party accredited to assess whether a product meets certain preordained standards – audits a manufacturer’s quality management system, checks technical documentation, examines the design dossier and finally declares whether or not the medical device is in conformity with the current requirements.
Manufacturers: keep up to date
So how can manufacturers prepare and stay updated regarding medical device legislation changes? Besides selecting an appropriate notified body, they should start implementing a Quality Management System (QMS) that is compliant with current regulations as soon as possible, consistent with Annex II & V of the MDD and ISO 13485:2003. They also have to make sure technical documentation has been updated in line with current device design and manufacturing practices. In other words: keep informed and updated on medical device legislations and guidance documents. That’s the message I wanted to send to all the attendees in Barcelona.