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.
An MDR consultant plans and runs a medical device manufacturer's route to compliance with Regulation (EU) 2017/745: gap analysis, classification, quality management system implementation, the GSPR and risk file, clinical evaluation (CER) and PMCF, technical documentation, notified body selection and
ISO 13485 is the quality management system (QMS) standard for medical devices; the current version is ISO 13485:2016. It defines the processes that let an organisation consistently meet customer and regulatory requirements across the design, manufacture, storage, distribution and servicing of medica
The PRRC (Person Responsible for Regulatory Compliance) is the competent person that every manufacturer and every authorised representative must have within its organisation under Article 15 of the EU MDR (Regulation (EU) 2017/745). There must be at least one; qualification requires either a degree
The EU MDR (Regulation (EU) 2017/745) defines four "economic operators": the manufacturer (Article 10), the authorised representative / EC REP (Articles 11–12), the importer (Article 13) and the distributor (Article 14). Each has distinct legal obligations — responsibility does not sit with the manu
The cost of EU MDR (Regulation (EU) 2017/745) compliance cannot be reduced to one number; it depends on device class, the maturity of your existing documentation, the testing required, and the clinical data need. As an indication: for a Class IIa device, compliance from scratch totals roughly €60,00
Affixing the CE mark to a medical device under the EU MDR (Regulation (EU) 2017/745) runs through eight core steps: (1) qualify the device, (2) classify it, (3) implement an ISO 13485-based quality management system, (4) build the GSPR conformity and risk management file, (5) compile the technical d
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.
