Medical devices are used to diagnose, prevent, monitor, treat or alleviate a disease by means of a physiological way of action. Medical apps which may be used to diagnose or help in the treatment of a patient can sometimes be considered as medical device as well. Medical devices in Europe must comply with Regulation 2017/745 (MDR) or the European Directive Directive 93/42/EC (MDD). The certification procedure of a medical device is dependent on the classification of the involved product and usually (except for class I medical devices) a Notified Body approves the application. All medical devices can be recognized by the CE symbol on the packaging material.

Regulatory documentation and services for medical devices

We advise on the classification of a medical device; the classification of legacy devices can be changed due to new classification rules in the MDR compared to those in the MDD. We also advise on certification and notification procedures. We were involved in the following types of medical devices; class I, IIa, IIB, and III (drug containing medical devices) including i.e. OTC medical devices, substance based medical devices, and wound dressings. 

The activities included the writing of various parts of Technical Files according to the applicable guidance documents (MED Dev’s, MDCG’s, ISO’s);

• i.e. manufacturing documents,
• Post Marketing Surveillance (PMS) Reports,
• Post Marketing Clinical Follow-up (PMCF) Plans, Protocols, and Reports,
• Biological Safety Evaluation Plans/Reports (BSEP/BSER),
• Clinical Evaluation Plans/Reports (CEP/CER),
• ADME Reports.

We were also involved in communication with Notified Bodies and Technical File reviews and we cooperated with QA/QC managers during ISO 13485/9001 certification procedures.

Do you need assistance in your MDR procedures?

The new Medical Device Regulation 2017/745 (MDR) has created a lot of excitement in the medical device world. Unfortunately, the guidance documentation has been published fairly late. 

Meanwhile, most legal manufacturers have identified the GAPs in their CE Technical Files between the MDD (Medical Device Directive) and the MDR and have performed additional tests and studies in order to close the identified GAPs. A lot of Technical Files are now under evaluation at the Notified Bodies.

The clinical evidence in the Post-Market Clinical Follow-Up (PMCF) and the CER are the most commonly identified non conformities under the new MDR. In addition, biocompatibility (tests) are also a commonly identified problem.

Please contact us if you need assistance during the transition to the MDR. We can compile or update various parts of your CE MDR Technical File. Moreover, we can assist during the evaluation of your notified body.