GMP News - Medical Devices

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?

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?

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.

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.

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.

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.

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.

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.

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.

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.

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.

16.08.18

New WHO guideline on medical devices and IVDs

On 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".

13.06.18

FDA opens Docket on Software Products

The U.S. Food and Drug Administration, FDA, recently opened a docket on specific types of software, including general wellness software products, electronic patient records and more.

19.12.17

Warning Letter on Combination Products 21 CFR 4

For several years, combination products have been regulated by 21 CFR 4 in the USA. In September 2017, the FDA issued a Warning Letter to a manufacturer of combination products. What did the FDA criticise?

19.12.17

2017 Medical Devices Warning Letters Statistics

In the first half of Fiscal Year 2017 review you could read about the Warning Letters issued to manufacturers of medical devices during 1 October 2016 through 31 March, 2017. Now, the numbers of Medical Device Warning Letters for the entire fiscal year 2017 (1 October 2016 - 30 September 2017) are available.

Page 5 of 10

European GMPs and the Role of the Qualified Person (QP) (Day 1 and 2) + Clinical Trial Supplies (Day 3) – Live Online Training

Recommended Event

11-13 July 2023

European GMPs and the Role of the Qualified Person (QP) (Day 1 and 2) + Clinical Trial Supplies (Day 3) – Live Online Training The Impact of EU Legislation on the Supply Chain

GMP News - Medical Devices

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

Things to Consider for Medical Device Manufacturers when Relocating

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

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

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

EU guidance for new Medical Device Regulation (MDR)

Borderline questions on medical devices

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

Data Integrity: Best Practices for using eHRs in Clinical Investigations

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

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

New WHO guideline on medical devices and IVDs

FDA opens Docket on Software Products

Warning Letter on Combination Products 21 CFR 4

2017 Medical Devices Warning Letters Statistics

Recommended Event

European GMPs and the Role of the Qualified Person (QP) (Day 1 and 2) + Clinical Trial Supplies (Day 3) – Live Online Training The Impact of EU Legislation on the Supply Chain

GMP Newsletter

GMP Conferences by Topics