When developing a new product, it isn’t enough to simply have a great idea. You need to ensure it meets and complies with relevant regulations, standards, and legislation, and this is incredibly important when it comes to medical devices. Medical device development involves a lot of confirming and checking that plans will meet the correct guidance, and in recent years, sustainability has become a huge part of this guidance as well.
Sustainability is a focus for so many businesses, consumers, and governments at the minute, and quite rightly so. This means there is a lot of new and emerging legislation surrounding the sustainability of new medical devices and needs to be considered in the development stages.
At 4D Products, we know that regulations and compliance for new products can be complicated, particularly in the medical industry. In this guide, we are sharing everything you need to know about the regulations, standards, and legislation surrounding medical device development.
Know Your Terminology
Before we dive into the guidance and obligations surrounding medical device development, it is worth clarifying the terms used in this guide:
- Regulations: A regulation is a subset of a legislation which typically describes a specific requirement. These are binding acts and apply across the EU.
- Legislation: Primary legislation sets out ground rules for the EU, there is also secondary legislation which is proposed by a legislative body.
- Standards: Standards are either advice/guidance or requirements which must be met in order to guarantee compliance. They are usually a set of principles.
What Are The Regulations, Standards, And Legislation For Developing Medical Devices?
The following regulations, standards and legislation must be taken into consideration when developing new medical devices:
All new products, whether for medical use or not, must meet various environmental standards set out in ISO14000. Not only that, but there is an increasing demand for products and manufacturers which are 14001 certified.
Reusability, Repairability, And Upgradeability
One design standard which teams must consider when designing new medical products is En45554. It sets out guidelines on designing products which fit into a circular economy.
Medical Device Considerations
Medical products differ from most standard products as they are very tightly controlled for efficacy and safety. In some cases, this means sustainability has to take a back seat, but legislation is beginning to change to bring in new regulations which allow for more sustainable medical device development. Some key considerations are:
- Providing instructions for disposal of medical devices with the products.
- Tighter regulations for SUDs, including labelling and tracking, are laid out in 21 CFR.
- Reprocessors of medical devices are considered to be manufacturers as stated in MDR Article 17. This means they must comply with all MDR obligations.
- Grandfather rights are no longer acceptable.
- Medical devices cannot use recycled plastics in their primary packaging.
- Environmental risk assessments must be completed for the product life cycle.
Packaging For Pharmaceuticals
There are some specific guidelines for packaging of pharmaceutical products:
- EU Regulation 2017/745 for medical devices
- EU Regulation 2017,746 for in vitro diagnostic medical devices
- Eudralex Volume 3 contains guidelines for plastic immediate packaging materials
- Eudralex Volume 4 provides guidelines for Good Manufacturing Practice (GMP)
European Batteries Directive
Medical devices which use or contain batteries must meet relevant regulations. The Batteries Directive regulates the manufacture and disposal of all kinds of batteries within the EU, and any medical products used in EU countries must follow this. Under these regulations, marketing of batteries which contain hazardous substances is prohibited. It also lays out measures for collection and recycling of battery products, and provisions for labelling.
REACH stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals and comes under the EC Regulation No 1907/2006. It aims to protect human health and the environment by early identification of the properties of chemical substances.
RoSH2 stands for Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment. It aims to cut back on the levels of cadmium, lead, polybrominated biphenyl (pbb), mercury, hexavalent chromium, and polybrominated diphenyl ether (PBDE) in products.
The WEEE directive is in place to minimise the impact that electronic goods have on the environment by reducing the amount of waste and increasing the recycling and reuse of these products.
Waste Packaging Directive
Manufacturers are required to prevent the creation of packaging waste and ensure that the volume and weight or packaging is kept to a minimum.
At 4D Products, we have helped develop many medical devices and have an in-depth knowledge on all the relevant standards, regulations, and legislations in place surrounding these products. For advice and guidance, contact our experts today.