Regulations governing medical devices – a guide

The most regulated industries are those which have the deepest impact on people’s lives and the potential to cause the most harm. It’s no surprise then to find healthcare at the top of the list of the most regulated industries.

During the course of their work, medical practitioners poke, prod, test, prescribe and administer. With every patient interaction involving drugs, equipment and devices there is the potential for harm to be done, both to the patient and the practitioner. Understandably, therefore, stringent rules and regulations are applied to the manufacture of medical devices, drugs and equipment to ensure the safety of all.

Here we provide a brief guide of regulatory compliance in contract medical device manufacturing.

Ensuring compliance throughout

To freely market your medical device, you need to be assured that your device, regardless of class, complies with the MDD and if required FDA regulations. This makes it crucial to be working with a contract manufacturing partner that has expertise in the design, prototyping, assembly and supply of medical devices and is also certified appropriately.

At the design and prototyping stage, it is vital to prepare the technical file that will declare the conformity to the MDD. You will also need someone with regulatory experience to address the additional testing required for sterile devices, if this is necessary. You will need to register your device with your notified body, and apply for the CE audit well in advance. Audit lead-times can be around 12 months, so get booked in as soon as is practical.

During product rationalisation, you should choose a company with the facilities and expertise to provide the Quality Assurance to manage the regulatory aspects of your production. As a leading medical device manufacturer, our quality system complies with the latest European and FDA standards. We can also help with the design and development of packaging and labelling for your medical products, ensuring these are compliant too.

Conforming to the Medical Devices Directive

Once approved by your notified body, a CE mark may be placed on a medical device or its packaging to show that it conforms to the requirements of the Medical Devices Directive (MDD). It is evidence that the device is fit-for-purpose intended, and meets legislation relating to safety. The classification of the device will define the assessment that the device will be expected to have undergone. If you are unsure about any aspect of the device classification, please contact a member of our QA team, who will be happy to discuss the classification rules.

Once achieved, the CE mark gives the manufacturer the freedom to market the device anywhere in the European Union. The original equipment manufacturer retains the legal responsibility for the product and must hold the relevant CE certificate. In most cases the subcontract manufacturer is deemed the supplier, and the company holding the CE mark for the device is the manufacturer. Meridian Medical works with a number of subcontract regulatory experts who could help you attain your CE certificate or manage the whole of your quality system.

The validation vs verification

Validation and verification are two essential aspects of the manufacturing process of medical devices.

Validation is the process of proving that the manufacturing process repeatedly produces the correct medical device. Verification is the process of checking each piece of medical equipment to ensure that it meets the design specification. To be considered compliant, each device must be examined and tested, ensuring that a homogenous batch of products is being produced.

Among the key attributes to look for in a contractor manufacturer of medical devices is their dedication to regulatory compliance and the quality of their facilities and equipment. Both validation and verification are key factors in reducing risk, which is essential for any medical device.

Meridian Medical is an established and experienced contract medical equipment manufacturer, specialising in a wide range of medical device design, development and supply services.

To find out more about how Meridian Medical can help you with your medical product design and manufacture, get in touch today by filling out our online form, calling us on 01903 732344 or emailing info@meridian-medical.com.

Regulations governing medical devices – a guide