KPMG Advisory stated in April 2021: “While the outlook for medical device companies appears positive, unsustainable healthcare costs and new competitive forces threaten to alter the future industry landscape…” The medical device industry is a fast-growing, lucrative industry however, are product manufacturers able to keep up? With many new regulations and evolving legislation for products globally, medical device manufacturers must act now to ensure the viability and longevity of their products into the future.
With Brexit officially being enforced from 1 January 2021, any product importers from the European Union were originally due to apply the UK Conformity Assessed (UKCA) Marking to all products by the end of 2021. The UK government announced on 24th August 2021 that businesses will have an additional year to apply new product safety markings for most products placed on the market in England, Scotland and Wales.
In between design, manufacturing, distribution and ensuring compliance, companies can have a lot of things to manage with their products. Fulfilment service providers essentially provide relief for companies and take care of many tasks such as warehousing, ordering, data maintenance, shipping, and returns management. Fulfilment service providers are now considered economic operators in the European Union. Here are five facts you should know about them.
Are you a company based outside of the European Union who is looking for an Authorised Representative? Not sure where to start? When selecting an EU Authorised Representative, it is important that you base your decision on criteria that will allow for longevity and sustainability in the relationship. In this article, we have outlined several points to look out for when selecting your EU Authorised Representative.
Comprehensive Guide on European Authorised Representatives and the new Market Surveillance Regulation
Authorised Representatives are imperative for any non-EU businesses wishing to place their products on the EU marketplace. With the new Market Surveillance Regulation 2019/1020 in force from 16th July 2021, it is now more important than ever for non-EU businesses to appoint an Authorised Representative to ensure that their products are following the correct procedure to enter the European Union.
2020 saw the e-commerce industry produce a record number of sales and increase its retail market share from 16% to 19%, indicating that e-commerce as the preferred way of consuming is on the rise. With this rise comes the importance of ensuring that trade and product manufacturing stays compliant the same way that physical product consumption does.
With the increase of knowledge surrounding global warming and other environmental risks, electric powered technology has become increasingly prevalent as more people, governments and organisations are implementing measures to encourage sustainable products. As the market for electric vehicles is accelerating, so too is the supply chain of such products, meaning that businesses need to adapt quickly to demand. With this comes the importance of ensuring that correct measures are taken into account to ensure product safety and sustainability of the parts themselves.
Ensuring product safety has many nuances. Where is your product being sold? What industry does it conform to? How has it been trialled and tested? What is it made out of? All of these factors will, in essence, affect whether or not your product is fit for the market. With a lot of information out there, we have simplified the preparation requirements so that you can easily ensure you are well-prepared for the initial phases of product certification.