GMP News - Medical Devices

31.07.19

EMA publishes Draft on Quality Requirements for Combination Products

The European Medicines Agency (EMA) has published a draft guideline on quality requirements for combinations of medicinal products and medical devices (so-called Drug Device Combinations - DDCs). What does the draft contain?

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18.07.19

Qualification of Development Tools for Medical Devices - FDA Website

In our News dated 25 September 2017, we announced the finalisation of an FDA guideline for the qualification of development tools for medical devices. Since this topic is very important for the FDA, a website has been dedicated to it. It is available on the Internet.

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18.07.19

Update of the borderline guideline on medical devices

At what point is a medical device to be considered a medical device in Europe? The classification of so-called borderline products is sometimes difficult. An updated EU guideline may be able to help.

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09.07.19

ATMPs in combination with a medical device - QP task on release

With the coming into force of the Advanced Therapy Medicinal Products (ATMPs) GMP rules as Part IV of the EU GMP Guidelines, a new chapter has been opened on the manufacture and quality control of ATMPs. Special requirements are placed on the QP when an ATMP is combined with a medical device.

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10.01.19

Cleaning Validation of Medical Devices: What should it look like? An ASTM Guide provides Answers

There are regulations for cleaning validation in the pharmaceutical sector and in the manufacture of active ingredients. But what about the cleaning validation of medical devices?

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10.01.19

Things to Consider for Medical Device Manufacturers when Relocating

In December 2018, the FDA  published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?

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10.01.19

Foreign FDA Inspections of Medical Device Manufacturers increase by 243% over the last 10 Years

In its "Medical Device Enforcement and Quality Report", the FDA has published current data on its monitoring activities with regard to medical device manufacturers. Find out what's new.

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19.12.18

New Ph. Eur. Structure of Chapter 3 on Materials and Containers

The Ph. Eur. Commission decided to restructure Ph. Eur. Section 3 on materials and containers. A new Subsection 3.3. has been added to cover items that are classified as medical devices according to EU legislation. Read more about 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.

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18.10.18

Medical Device Warning Letters - Fiscal Year 2018 - CAPA no longer in 1st Place

You can regularly read about an evaluation of the deficiencies in FDA warning letters concerning medical devices. Find out what the past fiscal year looked like in terms of FDA Warning Letters regarding medical devices and what changed compared to fiscal year 2017.

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18.10.18

EU guidance for new Medical Device Regulation (MDR)

With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.

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18.10.18

Borderline questions on medical devices

At what point is a medical device considered a medical device in Europe? So-called borderline products sometimes cause problems regarding classification; a guideline on Borderline products by the European Union may be of help.

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26.09.18

New VDI Guidelines for Barrier Systems, Medical Devices and HVAC systems

In August, the Association of German Engineers (VDI ="Verein Deutscher Ingenieure") released three interesting VDI guidelines. The topics addressed are tightness of containment systems, identification of critical impurities in the manufacturing process of medical devices as well as requirements on the planning and implementation of central HVAC systems. Find out more about the new VDI guidelines.

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21.08.18

Data Integrity: Best Practices for using eHRs in Clinical Investigations

With the final guidance on the Use of Electronic Health Record Data in Clinical Investigations the US FDA intends to assist sponsors, clinical investigators, contract research organizations (CRO´s), institutional review boards (IRBs), and other interested parties in the use of eHR data in clinical investigations.

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16.08.18

Notably low number of warning letters issued to device manufacturers in first half of fiscal year 2018

The evaluation of the FDA warning letters regarding medical devices of the first half of fiscal year 2017 yielded a remarkable low number of warning letters. Find out, what the evaluation of the medical devices warning letters in the first half of fiscal year 2018 showed.

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16.08.18

What makes a medical device a medical device? New FDA guideline on product classification

On twelve pages, the new FDA guideline entitled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drug products, medical devices or others.

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