Your Partner for Quality and Regulatory Compliance
in MEDICAL DEVICE INDUSTRY
With 15+ years experience we are constantly working for better service...
Our Services
Whether you are a small start-up, requiring an effective regulatory watch or a mature company looking for detailed.
During Covid 19 we offer remote in house training courses to improve staff knowledge, competency and regulatory skills…
Medloft helps you ensure that your medical device complies with the applicable standards and regulatory requirements…..
Hot Topics
The new date of application of MDR is 26 May 2021. If you plan to CE Mark your medical device or prepare for MDR transition, this “How to?” article maybe useful for you…
Premarket notification process, known as a 510 K submission, is required for Class II devices to enter the US Medical Device Market…
This 2016 revision of the standard provides a basis for the quality management system in parallel to the EU MDR and other international regulatory changes…
The implementation of the ISO 14971 standard by the manufacturer is the most appropriate solution to ensure the requirements for risk management…
Latest News
EUDAMED Single Registration Number
The first module of the EUDAMED (European Databank on Medical Devices ) will be live as of 1st December of 2020. This will enable economic operators to get a Single Registration Number (SRN). MDR Registration Requirements As you know, Chapter III of the MDR EU 2017/45 deals with identification and traceability of medical devices including […]
Single Use Medical Device Reprocessing
Single use medical device reprocessing has always been a challenge for many health institutions. The new medical device regulation (MDR) EU 2017/745 defines requirements for “single-use devices and their reprocessing” in Article 17. On 19th of August 2020, EU commission issued the implementing regulation 2020/1207 as regards common specifications (CS) for the reprocessing of single-use […]
UDI – Unique Device Identification System
The EU Commission issued Q&A document for Unique Device Identification (UDI) System. This guidance document gives an overview of the new UDI system and obligations of operators, which have to be fulfilled to CE Mark a medical device. For other details you can check our article “How to CE Mark a Medical Device” The UDI […]
The Number of Medical Device Notified Bodies is increasing
On 8th of August 2020 EU Commission has announced EU MDR 2017/745 designation of DQS Medizinprodukte GmbH as the 16th notified body (NB). But the question “Have we enough Medical Device Notified Bodies for EU Market?” remains open. Since beginning of 2019, when BSI Assurance UK Ltd (0086) has been designated as the first NB […]
Latest Articles
PMCF, PMS and PSUR Requirements
PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging new MDR (EU 2017/745) requirements. As many of you know, MDR has increased requirements for clinical evaluation and market surveillance. The importance of the clinical data shows its effects for post market surveillance as a more detailed PMCF process. Of course this shall […]
MDR Technical Documentation Requirements
MDR Technical documentation requirements will be one of the main challenges for the medical device manufacturers during transition from 93/42/EEC (MDD) to EU 2017/745 (MDR). As explained on “How to CE Mark your medical device” article, preparation of the technical file is a critical milestone. Since there is no grandfathering for the devices on the […]
EU Medical Device Regulation – How to CE Mark a Medical Device ?
CE mark is required for each medical device sold in EU. Due to the Covid-19 pandemic the date of application of the new EU medical device regulation (EU 2017/745) has been postponed to 26th May 2021. Until this date, Medical Device Directive 93/42/EEC may be still used for the initial certification. A medical device which […]
Implant Card Requirements of MDR
Implant card (IC) is one of the new requirements of the MDR – EU 2017/745. The requirements specified in Article 18 will bring new challenges to the daily life of the implantable device manufacturers. The guidance MDCG 2019-8 includes useful hints, which will help the manufacturers during design of an IC. Before diving into details […]