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Dealing with the new medical device regulations

The three existing Medical Device Directives are in the process of being replaced with two Regulations. Jean-Louis Evans, managing director at TÜV SÜD Product Service, looks at the implications for designers of medical equipment in the EU.

There's a big change coming for medical equipment designers, with two new Regulations just around the corner. 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.

One reason for the change from a directive to 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. The anticipated date for approval of the Regulations is after the 2014 European Parliament elections in May.

During the transition 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 and Healthcare products Regulatory Agency (MHRA). They will also have to register their device on the Unique Device Identification (UDI) System, which will deliver full traceability of every individual device on the European market. If manufacturers don't comply with the Regulations' new requirements, their medical devices may not be legally allowed to remain on sale within the EU after the end of the transition date.

Wider impact

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. Class I is considered low-risk, class IIa is medium-risk (eg tracheal tubes, dental filling material, etc), the medium-risk class IIb includes items such as X-ray machines, bone plates and screws, while class III devices are considered high-risk (eg 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 means that there is a new set of markets that may not be aware of how the requirements affect them or that may not have the processes in place to ensure that they can comply.

Even those manufacturers, which are fully up to speed and understand that the specific requirements for their devices will not change, must update their quality systems documentation to incorporate references to the new Regulation. This is not a quick five minute task as every document which refers to the current Directives must be updated to reflect the new Regulation.

Notified Bodies

As part of the EC's goal for stronger supervision of independent assessment bodies by national authorities, another change is that every Notified Body will be de-notified and must reapply, it is anticipated that far fewer will be re-notified.

There is a new opportunity for manufacturers of class III devices in that some Notified Bodies, but not all, will be permitted to assess these devices. Manufacturers, which currently have certified products, will be able to transfer that certification to another Notified Body under the new Regulation. 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 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 24 September 2013, the European Union 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 that will come in to force in 2014. The exact details are left up to the individual Notified Bodies to implement but it will involve a visit to manufacturers within a three year period, and may also include an unannounced visit to key suppliers, both of which the manufacturer must pay for.

It is clear that the requirements will become tighter, with increased Notified Body involvement in some new areas. For example, manufacturers of some low risk Class I devices (eg sticking plasters, corrective glasses) 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.

As many manufacturers will be required to comply for the first time there will be a significant increase in the numbers starting the compliance process. The equally significant decrease in the number of Notified Bodies, which will need to support these manufacturers, will make time to market delays and product unavailability inevitable. It is therefore imperative that manufacturers of electronic medical devices take action now to thoroughly understand how they must apply the changes.
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