The ever-evolving regulatory landscape increasingly emphasises the responsibility for manufacturers to demonstrate proactive monitoring of their products after they have been placed on the market. It’s therefore vital that device manufacturers have thorough post-market surveillance systems in place to collect vigilance data, supporting the continued safety and efficacy of the product, as well as minimising any risks to end-users.
Maintaining compliance can be one of the most difficult steps in the regulatory process, but our MedTech consultants can help to develop an appropriate plan for your product so you can understand and fulfil your obligations at the post-market stage for the lifetime of the product.
Identifying the requirements and responsibilities for your product in the post-market period is essential to maintaining certification. A manufacturer must ask what needs to be done to continue to manage and mitigate risks. For example, is the product a Well-Established Technology (WET) and therefore the risk is already well understood, or is it a new and original Class III product that needs to be more intensively monitored?
We will support you in identifying and interpreting the relevant sections of the device regulations and develop a plan that’s appropriate for your particular type of product, keeping surveillance up to date for maintaining your certification.
The EU’s Medical Device Regulation (MDR) defines Post-Market Surveillance (PMS) as “all activities carried out by the manufacturer… to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market.” This proactive approach is integral to our PMS strategy — and is why Post-Market Clinical Follow-Up Studies are integral to the process.
At Woodley BioReg, our team of MedTech specialists will support you in implementing your Post-Market Surveillance strategies for effective compliance and the maintenance of end-user safety.
An authorised representative is a contact that acts on behalf of a manufacturer that is based in the market / region as the main point of contact with authorities for a product that is being distributed within it. To access the EU market from outside, an Authorised Representative (AR) would need to be based in one of the 27 member states. To access the post-Brexit UK market from outside, an equivalent ‘UK Responsible Person’ (UKRP) based in the UK must be appointed.
At Woodley BioReg, we can act as your Authorised Representative / UK Responsible Person in both regions, having registered offices in Huddersfield, UK and Milan, Italy. Our team of import professionals can assist with CE and UKCA marking, and you will be able to licence the use of our EU and UK addresses — meaning you can be confident that you’re in safe hands.
