INDUSTRY FOCUS MEDICAL EQUIPMENT From directives to regulations
A European Commission (EC) review of the Medical Device Directives has resulted in a proposal for a new regulation to replace both Directive 90/385/EEC (active implantable medical devices) and Directive 93/42/EEC (medical devices), with a separate regulation to replace Directive 98/79/EC (in vitro diagnostic medical devices). Jean-Louis Evans, managing director at TÜV SÜD Product Service, helps to clear things up
he change from a directive to a regulation means that European Union (EU) countries will no longer be able to interpret and implement the Medical Directives’ rules in different ways, but must accept it into their country’s law in its entirety - unchanged. The EC states that these changes will
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help manufacturers as there will be clearer rules, easier trading between EU countries and a level playing field, with penalties for those who do not play by the rules. The new rules also take particular account of the specific needs of the many small and medium sized manufacturers in the medical device industry.
The anticipated date for approval of the regulations is after the 2014 European Parliament elections in May, with an end transition date of 2017. During this time there are a number of different ‘compliance by’ dates by which manufacturers will have to abide. This includes registration 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 of the new regulation. This also includes ‘authorised representatives’, which any non-European manufacturer must have based within the EU. To keep pace with technological and
scientific progress, the new regulations will divide medical devices into four different risk categories and health and safety requirements, including labelling rules. This class expansion means that new industries will be included for the first time and they may not be aware of how the requirements affect them or have the processes in place to ensure that they can comply. Even manufacturers of devices where
requirements will not change must update their quality systems documentation to
36 MARCH 2014 | AUTOMATION
incorporate references to the new regulation - not a quick five minute task.
NOTIFIED BODIES Another change is that every Notified Body will be de-notified and must reapply, and it is anticipated that far fewer will be re-notified. Products certified by an old Notified Body that is no longer recognised may be required to conduct a full assessment before transfer to a new Notified Body. This will inevitably create bottlenecks, with products being taken off the market until they are re-certified, while some may not be suitable for re-certification. 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, giving manufacturers little time to act. On 24th September 2013 the EC
published a recommendation document, which is now legally enforceable and places a direct responsibility on Notified Bodies, to conduct unannounced visits ahead of the full Medical Device Regulations coming into force later this year. This is in addition to the surveillance audits that are currently undertaken. This will mean that over the next three years all legal manufacturers can expect an unannounced visit from a Notified Body, which for some will also include a visit to their key suppliers. There is also new Notified Body
involvement in some areas that were not
Above: to keep pace with technological and scientific progress, the new regulations will divide medical devices into four different risk categories and health and safety requirements, including labelling rules
previously included. For example, for the first time, 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.
Below: the new rules take particular account of the specific needs of the many small and medium sized
manufacturers in the medical device industry
REDUCING THE IMPACT With an expected significant decrease in the number of Notified Bodies and an increase in the number of manufacturers needing their support, many of which must comply for the first time and must start the compliance process entirely from scratch, market delays and product unavailability is inevitable. It is therefore imperative that the
supply chain (designers, manufacturers, importers, distributors and authorised representatives) get expert support to thoroughly understand how they must apply the changes. For those that are prepared, they can carry on selling product after 2017, while their unprepared competitors may have to withdraw products from the market.
TÜV SÜD Product Service
www.tuv-sud.co.uk T: 01489 558 100
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