Registration of legacy devices in the UK: The EU MDR transitional arrangements have been amended to extend the validity of EU MDD and EU AIMDD CE certificates, subject to meeting certain conditions. The validity has been extended to 31 December 2027 for higher risk devices (Class III and IIb implantable devices) and 31 December 2028 […]
The New Machinery Regulation: At Certification Experts, we strive for the safety of people. Safe interaction with machinery is a key topic in this matter. That is why on this specific day, #bewustveilig2023 (Safety Awareness day 2023 at work), we would like to have a moment to shed light on the new regulation that will […]
We expect many developments within our field of expertise for 2023. These are the main developments of which we are certain that they will impact you. In this blogpost we will briefly explain what changes will occur, how this will impact you, and how we can help you handle them. You can expect more detailed […]
Recently the Health Care and Youth Post Inspectorate brought out a post regarding electric wheelchairs. In the article the importance of having a good Risk Management system in place was illustrated, along with showing how a product with low risk does not mean it is without risk. To add onto this, the Post also elaborated […]
A Complete Guide to Medical Device Certification and Compliance in the European Union and the United Kingdom
In the European Union and the United Kingdom, there are specific regulatory and legal perimeters that apply to the manufacturing and distribution of medical devices. We have developed this comprehensive guide to assist manufacturers who are either based in these regions or who plan to sell their medical device products on either of these markets.