Time for change

From digital thermometers to pacemakers, The European Commission are revising the Medical Device Directive for such articles. Jean-Louis Evans looks at the impact this could have On 26th September 2012 the European Commission (EC) adopted a package on innovation in health. This is intended to improve the communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals. A statement in the EC’s Citizens’ Summary document, which relates to these changes, cites a key issue for this change as the need for healthcare professionals and other interested parties to have access to essential information on how medical devices have been assessed, as well as what clinical evidence there is to show that they are safe and effective. The European Union (EU) is proposing updated regulations on a wide range of medical devices. This includes home-use items such as digital thermometers and blood pressure meters, as well as more complex technologies such as x-ray machines and pacemakers. The aim is to ensure that all of these products are safe, and can be freely and fairly traded throughout the EU. The EC is therefore currently leading a review of the Medical Device Directives, calling 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 new Regulations have become necessary as the EC believes that existing rules, which date back to the 1990s, have not kept pace with the enormous technological and scientific progress of the last 20 years. The final drafts of the Regulations are now with Member States for their review, and early feedback within the UK community suggests that there will be no requests for major changes. One reason for the change, from a Directive to a Regulation, is that EU countries can currently interpret and implement the Medical Directives’ rules in different ways. This allows 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, unchanged. The EC states that not only are these changes intended to safeguard patients and healthcare professionals, they will also help manufacturers as there will be clearer rules, easier trading between EU countries and a level playing field, with penalties for those who don't play by the rules. The new rules also support patient-oriented innovation and take particular account of the specific needs of the many small and medium-sized manufacturers in the medical device industry. Once feedback from the Member States is completed, the anticipated date for approval of the Regulations by the European Parliament is 2014, and they are expected to come into force in 2017. In order to ensure that compliance deadlines set by the EC are met, manufacturers of medical devices should take concrete action now. Initially, this should include a full assessment of the likely impact of the Regulations upon their design and manufacturing processes. Otherwise, if they don’t comply with the Regulations’ new requirements by 2017, their medical devices may not be legally allowed to remain on sale within the EU. In the past it has sometimes proven not to be possible to trace medical devices back to their supplier. Therefore, in order to improve traceability of medical devices throughout the supply chain, new rules will be introduced. Consequently, manufacturers will have to register their device on the Unique Device Identification System (UDI). This is a unique number relating to a medical device, enabling its identification and giving access to relevant information stored within the UDI database. Not only will this deliver full traceability of every individual device on the European market, it is intended to allow easier recall of faulty devices and help in the fight against counterfeit goods entering the EU. During the transition period, between Directive and Regulation, manufacturers of medical equipment will also have to register with their country’s competent authority, which in the UK is the Medicines & Healthcare products Regulatory Agency (MHRA). The Regulation also means that importers and distributors of medical devices will now be affected as for the first time they will have to comply with the requirements. For some of them, being expected to fully understand and implement the legal requirements will be a daunting task. They will not previously have needed to make such allowances, as until now the onus was placed upon the manufacturer. ‘Authorised representatives’ will also be included for the first time. These are legal entities, designated by non-EU manufacturers to represent them in the EU and 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, who may be wary of the possibility of confidential data or verbal information becoming accessible to their competitors and must therefore carefully select the authorised representative they work with.

Not only are these changes intended to safeguard patients and healthcare professionals, they will also help manufacturers as there will be clearer rules, easier trading between EU countries and a level playing field, with penalties for those who don't play by the rules

To keep pace with technological and scientific progress, the new Regulations will divide medical devices into four different risk categories and health & safety requirements, including labelling rules. Class I is considered low-risk, class IIa is medium-risk (e.g. tracheal tubes, dental filling material), the medium-risk class IIb includes items such as X-ray machines, bone plates and screws, while class III devices are considered high-risk (e.g. heart valves, total hip replacements, breast implants). The class expansion means that new industries will also be included for the first time, such as cosmetic surgery, liposuction and non-corrective contact lenses. This will result in the inclusion of a new set of markets that may not be aware of how the requirements affect them, or that may not have the processes already in place to ensure compliance. This could therefore represent an uphill struggle for any of those industries caught within the net of the new Regulation for the first time, requiring a significant amount of time and cost to ensure that they are fully up to speed and compliant. Even those manufacturers, whose specific device requirements will not change, will have to update their quality systems documentation to incorporate references to the new Regulation. There are also changes to the approach for the declaration of conformity for individual products. This creates more administration and is not a quick five minute task as every document, which refers to the current Directive, must be updated to reflect the new Regulation. As part of the EC’s goal for stronger supervision of independent assessment bodies by national authorities, every Notified Body will be de-notified and will have to re-apply. Of the 70-80 that currently exist, it is anticipated that far fewer will be re-notified. Some Notified Bodies may choose not to re-apply for cost reasons, or the competent authority in each country may no longer consider that the Notified Body meets the requirements and will not re-notify them. If manufacturers have certified products under an obsolete Notified Body, they will be able to transfer that certification to another Notified Body under the new Regulation. They will even have to do this if their product has been available on the market for years. However, if the product was certified by an old Notified Body that is no longer recognised, then the new one may decide to conduct a full assessment before transfer. This will inevitably create bottlenecks, with products being taken off the market until they are re-certified, while some may prove not to be suitable for re-certification 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 re-notified during the transition period of moving form Directive to Regulation status, giving manufacturers little time to act. Also, as the EC wants to give more power to assessment bodies to ensure thorough testing and regular checks on manufacturers, the Regulations propose that the Notified Body make unannounced factory inspections, in addition to the surveillance audits that are currently undertaken. At the moment, it is unclear who will pay (the manufacturer or the Notified Body) and the process involved. For example, the Notified Body that arrives unannounced may find that the staff they need to meet, in order to access relevant files and other information relating to a product, are unavailable as the visit was not prearranged – a waste of both time and money. While the Regulations are not yet finalised and the scope unclear, it is likely that Notified Body involvement may be required for some low risk Class I devices (e.g. sticking plasters, corrective glasses). For the first time, these Class I manufacturers will be required to provide technical files for review by a Notified Body, otherwise 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 that there is a whole new set of manufacturers that may not already have the processes in place to ensure that they can comply and will therefore have to start from scratch. The Notified Bodies themselves will also come under greater scrutiny as they will be regularly audited by the Competent Authority in their own country, plus one other from another EU Member State alongside a representative of the EC as the lead auditor. With the significant increase in the number of manufacturers that will be impacted by the new requirements of a medical device regulation, many of which must comply for the first time and must start the compliance process entirely from scratch, time to market delays and product unavailability are inevitable. The equally significant decrease in the number of Notified Bodies, which will need to support these manufacturers, will only heighten the situation. It is therefore imperative that manufacturers of medical devices take action now to thoroughly understand how they must apply the changes. For those that are prepared, this could turn into a competitive advantage as they will be able carry on selling after 2017, while their unprepared competitors may have to withdraw products from the market. Author Jean-Louis Evans is Managing Director at TÜV SÜD Product Service, a global product testing and certification organisation