CE marking of medical devices.

You need this when you are bringing a new device to the European market, moving an existing device over to the MDR, or when your CE marking project has stalled with a notified body. Notified body timelines are hard to predict and their fees are high, so getting the qualification, classification and technical file right before submission saves both time and money. Large multinationals use MEDCOR as extra regulatory capacity; SMEs use MEDCOR to guide them through the full exercise.

• —Qualification: checking whether your product is truly a medical device, or whether it sits on the borderline with medicines, cosmetics, food supplements or other products.
• —Classification: identifying the most appropriate classification rule under Annex VIII of the MDR, and documenting the rationale.
• —Review of the technical file and associated documents against Annexes II and III, so the notified body review runs as smoothly as possible.
• —Review and validation of labelling, artwork and instructions for use, and of the EU Declaration of Conformity, against the MDR 2017/745.
• —Advice on notified body selection, based on the scope and designation of each body.
• —EUDAMED registration of actors and devices, by manual upload or through a third-party vendor setting up a machine-to-machine (M2M) connection.
• —Switzerland: an introduction to a Swiss authorised representative (CH-REP) and follow-up of the Swissdamed registration.
• —United Kingdom: an introduction to a UK Responsible Person (UK RP) and follow-up of the device registration in the MHRA DORS database.
• —Regulatory intelligence: following what is being discussed at EU level on the future of the MDR, and what it means for your devices.

Qualification and classification decide everything that follows: the conformity assessment route, whether a notified body is needed, and the cost and duration of the whole project. MEDCOR is in contact with MedTech Europe, through its Regulatory Affairs and Borderline groups, which helps in judging borderline products and choosing the most appropriate classification rule. Often the claims decide it. In the European Commission's Manual on Borderline and Classification, a light box sold to treat seasonal affective disorder is a medical device, while wigs and head scarves for patients with hair loss are not, because their purpose is cosmetic.

The large, well-known notified bodies are not always the best choice. A smaller notified body can sometimes offer more availability, shorter lead times and a more direct relationship. Each notified body is designated for specific legislation and device codes, which can be looked up in the European Commission's NANDO database. You are welcome to take a look there yourself, and we then advise on the body that best fits your devices.

Once your device is CE marked, it needs to be registered. MEDCOR has experience with both manual upload to EUDAMED and upload through third-party vendors who set up M2M connections with EUDAMED. For companies active in Switzerland, we put you in touch with a CH-REP and make sure Swissdamed gets done. For the United Kingdom, we put you in touch with a UK Responsible Person and make sure the MHRA DORS database is filled in.

The future of the MDR is being actively discussed at EU level, with industry, including MedTech Europe, calling for significant changes in letters and reports to the European institutions. In its position paper The Future of Europe's Medical Technology Regulations, MedTech Europe reports that around 20% of medical device portfolios are expected to be discontinued in Europe, and that 48% of device manufacturers are deprioritising the EU as the first market for new devices, and it calls for a more efficient and predictable CE marking system. MEDCOR follows these discussions closely, so we can advise you on what may change and how to plan for it.