Market Access

 

In the current challenging and constantly evolving regulatory environment, international medical device companies must comply with a range of complex and sometimes confusing requirements.

The interplay of political, economic and patient safety requirements are forcing the advancement of Medical Device Regulations, which can vary across geographies and even within regions (e.g. EU MDD vs EU MDR, post-Brexit UK, Swiss-exit, and the Eurasian Union). Additionally, both consumer and regulator expectations are increasing, resulting in an increase in product reports and manufacturing inspections.

Large corporations have departments of specialists dedicated to supporting the monitoring of international regulations and the meeting of regulatory requirements that extend through the product lifecycle. Our unique Market Access support  will benefit organisations seeking to gain access to industry experts who can support both strategic planning and operational execution of go to market expansion activities. These industry experts have experience in global RAQA, Compliance & Ethics, Operations, and Mergers & Acquisitions.

With our collaborative approach we take the time to understand your target customer base, your portfolio of products, and your route to market and take our global experience to deliver a bespoke solution that works for you:

• We can be your UK Responsible Person should you wish to register a product manufactured outside the UK prior to placing it on the UK market. Our focus on “Right First Time” submissions optimises the time to market for your business.
• We can guide you through the differences between the regulations applying to Great Britain (England, Wales and Scotland) and Northern Ireland due to the nature of the post-Brexit agreement between the UK and the European Union.
• We can help you understand the requirements of the Swiss Medical Devices Ordinance (MepDO, effective from 26 May 2021) if you want continued access to the Swiss market as a foreign manufacturer, including the designation of an Authorised Representative in Switzerland.
• We can assist Swiss manufacturers with access to EU markets  as since the mutual recognition and any associated facilitation of trade of medical devices between the EU and Switzerland ceased to apply as of 26 May 2021, they must appoint an authorised representative in the EU.
• We can support development of global expansion activities in regions such as  North America and the Middle East.

Access to our expertise in regulatory intelligence, strategic market access planning and operational execution support comes at less than the cost of a junior in-house employee. Please do contact us so that we can discuss a tailored solution most appropriate for your business and customer needs.