Area
Regulatory
affairs.
Medical devices and in vitro diagnostics: the documentation that brings a product onto the European market and keeps it there.
MDR · IVDR · UDI
CE marking: MDR and IVDR
Regulations (EU) 2017/745 and 2017/746 raised the bar for everyone: heavier technical files, stronger clinical and performance evidence, continuous surveillance after the sale.
I draft and maintain technical documentation under Annexes II and III: device description and classification, general safety and performance requirements, risk management, verification and validation, clinical or performance evaluation. Alongside the file I take care of everything that leaves the company with the product — instructions for use, technical data sheets, labels compliant with ISO 15223-1, UDI codes and their barcodes, declarations of conformity — and the registrations required by the European database.
This is the area I work in daily for a manufacturer of diagnostic devices: from drafting the documents to keeping them current, including the revisions that every product or regulatory change brings with it.
- MDR and IVDR technical documentation, and its updating
- Instructions for use, technical data sheets and product literature
- Labelling, ISO 15223-1 symbols and UDI coding
- Declarations of conformity and dealings with the notified body
- Post-market surveillance and revision control
Let's talk.
Tell me what your company does and where you stand: one phone call is usually enough to see whether and how I can help.