Review of EU policies could bring problems for UK companies developing medical equipment

The European Commission is currently spearheading a review of the Medical Device Directives, which includes a proposal for a new Regulation to replace Directive 90/385/EEC (active implantable medical devices) and Directive 93/42/EEC (medical devices), as well as a separate Regulation to replace Directive 98/79/EC (in vitro diagnostic medical devices). The change from a Directive to a Regulation is significant; a Directive allows European Union (EU) Member States to adjust the legal text so that it can be aligned with the national legislation of that state. However, Member States cannot interpret the requirements of a regulation and must accept it into their country's law in its entirety. The industry should therefore be taking action now to fully assess the likely impact of the regulations upon their design and manufacturing processes, in order to ensure compliance within the deadlines set by European Commission is met. If not, their medical devices may not be legally allowed to remain for sale within the EU after 2017. The final draft of the Regulations was published on 26 September 2012 and it is now with Member States for their review. Early feedback within the UK community is that no requests will be made for major changes. Once feedback from the Member States is completed, the Regulations are anticipated to be approved by the European Parliament in 2014, with an expected date for them to come into force of 2017. During the transition period, manufacturers of medical equipment will have to register with their country's competent authority, which in the UK is the Medicines & Healthcare Products Regulatory Agency (MHRA). They will also have to register their device on the Unique Device Identification System (UDI), which will deliver full traceability of every individual device on the European market. The net widens For the first time, importers and distributors of medical devices will have to comply with the requirements. Being expected to fully understand and implement the legal requirements placed upon them will be a daunting task for some, because previously they were not expected to make such allowances – the onus was placed solely upon the manufacturer. 'Authorised representatives' are also required to comply for the first time. These serve as a legal entity, designated by non EU manufacturers to represent them in the EU and to ensure their compliance with the European Directives. By law, any non European manufacturer must have an authorised representative based within the EU. However, as authorised representatives are able to work with more than one manufacturer, their access to confidential product files may cause issues for manufacturers wary of the possibility of confidential data becoming accessible to their competitors. New industries will also be included, such as cosmetic surgery, including medical devices such as implants, liposuction and non corrective contact lenses. This means that there will be a new set of manufacturers that may not be aware of how the requirements affect them, or that may not have the processes already in place to ensure that they can comply. This could therefore represent an uphill struggle for any of those industries caught within the net of the new Regulations for the first time, requiring a significant amount of time and cost to ensure they are compliant. Even those manufacturers which are fully up to speed and who understand that the specific requirements for their devices will not change must update their quality systems documentation to incorporate references to the new Regulations. There are also changes to the approach for the Declaration of Conformity for individual products. This creates more administration and will not be a quick five minute task – every document which refers to the current Directives must be updated to reflect the new Regulations. Changes to the Notified Body system Another change is that every Notified Body will be denotified and must reapply. Of the 70 to 80 Notified Bodies that currently exist, it is anticipated that far fewer will be renotified. Some will choose not to reapply for cost reasons, while the competent authority in each country may no longer consider the Notified Body meets the requirements and it will not renotify it. Manufacturers who currently have products certified under an obsolete Notified Body, will be able to transfer that certification to another Notified Body under the new Regulations. However, if the product was certified by an old Notified Body that is no longer recognised, then the new one may be required to conduct a full assessment before transfer. This will inevitably create bottlenecks, with products being taken off the market until they are recertified, while some may prove not to be suitable for recertification under the new Regulation. Manufacturers therefore need to think carefully about which Notified Body they choose to work with from now on, especially as Notified Bodies will not be renotified during the transition period of moving from Directive to Regulation status. This gives manufacturers little time to act, should they need to change Notified Body after the deadline for renotification. The Regulations also propose that the Notified Body makes unannounced visits, in addition to the surveillance audits that are currently undertaken. At the moment, it is unclear whether the manufacturer or the Notified Body will pay for this and what the process may be. For example, the Notified Body that arrives unannounced may find the staff it needs to meet, in order to access relevant files and other information relating to a product, are unavailable because the visit was not prearranged – a waste of both time and money. While the Regulations are not finalised and the scope remains unclear, it is likely that Notified Body involvement may be required for some low risk Class I devices. For the first time, Class I manufacturers will be required to provide technical files for review by a Notified Body; if they don't, the product will not be approved and this could result in its removal from the market until that approval is granted. Once again, this means a whole new set of manufacturers may not have the necessary processes in place to ensure they can comply and will therefore have to start from scratch. Time is ticking Many manufacturers, importers, distributors and authorised representatives who must comply for the first time, will enter a new era and must instigate a new compliance process. However, as there will be more manufacturers needing the support of fewer Notified Bodies, time to market delays and product unavailability would appear to be inevitable. The clock is ticking and all medical device designers and manufacturers – along with their supply chains – must take action now to thoroughly understand how they must apply these changes and mitigate the impact of these delays on their businesses. Jean-Louis Evans is managing director of TÜV SÜD Product Service.