Practical guidance on MDR, ISO 13485, clinical evaluation and more.
Technical file, CER, GSPR, PMCF, PRRC — a complete document checklist structured by device class and Annex.
The EU MDR (Regulation (EU) 2017/745) became applicable on 26 May 2021. For devices certified under the MDD/AIMDD, Regulation (EU) 2023/607 extended the transition periods and removed the "sell-off" date. Where the conditions are met, existing certificates are recognised until 31 December 2027 for C
Software is Medical Device Software (MDSW) under the EU MDR (Regulation (EU) 2017/745) if its manufacturer intends it for one or more medical purposes (diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease) and it does this by processing data — not merely stor
The MDD (93/42/EEC) was a directive — a framework each member state transposed into national law, so it was open to interpretation differences between countries. The MDR (Regulation (EU) 2017/745) is a directly binding regulation applied the same way across the EU. The MDR widened the scope, raised
Under the EU MDR (Regulation (EU) 2017/745), every medical device falls into one of four classes based on its intended purpose and risk: Class I (low risk), Class IIa (low–medium), Class IIb (medium–high) and Class III (high risk). The class is determined by applying the 22 classification rules in A
The EU MDR — formally Regulation (EU) 2017/745 on medical devices — is the legal framework that governs how medical devices are placed on the market, made available, and monitored in the European Union. It was published on 5 May 2017, became applicable on 26 May 2021, and replaced the earlier Medica
Sınıfa göre €8.000–€600.000+ bütçe aralıkları, Onaylanmış Kuruluş ücretleri, ISO 13485 ve Türkiye ÜTS ek maliyetleri.
A practical breakdown of MDR's biggest shifts vs. MDD and what they mean for your device portfolio.
Step-by-step structure for Annex II & III dossiers that survive notified body review.
The 2019 revision quietly tightened expectations. Here's what your risk file must now include.
From CEP to literature appraisal to CER — a defensible methodology under MDCG 2020-13.
Actor IDs, UDI submission and the practical mechanics of the EU database.
How a chemistry-led approach under ISO 10993-1 can cut your test program in half.
