Medical device regulations are becoming increasingly complex, posing a real challenge to the whole medical device industry, particularly manufacturers, importers and distributors. SCC has been monitoring the recent developments, paying special attention to the most relevant issues, which we have outlined for you below.

Regulatory requirements for medical devices

For the EU member states, medical devices are presently regulated by national laws which, in turn, are based on the European directives (MDD) 93/42/EEC and 90/385/EEC and the in vitro diagnostics directive 98/79/EC. With the new medical device regulation MDR (EU) 2017/745 being enforced in May 2017, the regulations defined therein are valid uniformly in the European Union, after the time of the transition period has elapsed.

In the following, you can learn important aspects of the new MDR and what you need to know with respect to conformity assessments and the MDR implementation. With the transition period expiring on 26th May 2020, there is urgent need for action.

New MDR requirements and our services for implementation

>> New requirements MDR (EU) 2017/745

Risk assessment of medical devices according to ISO 14971

>> Risk management for medical devices

Biocompatibility of medical devices

>> Biological evaluation of medical devices in line with DIN EN ISO 10993

Clinical evaluation, literature search

>> Clinical evaluation of medical devices

Qualification and validation

>> Qualification and validation

International approval

>> International approval

Interesting links

>> Interesting links