Are you familiar with regulation (CE)? You know what to expect from the new MDR and IVDR 2017? Then they did your homework, do you think?

In Germany, 90 per cent of people are insured under statutory health insurance. The essential basis here is the German Social Code V (health insurance).

The SGB V is very financially and adminstrative-heavy. Concepts and topics such as evidence, studies, quality assurance, benefit assessment, additional benefit, patient use have taken a stronger influence in SGB V in the last few years. This applies in particular to the assessment of new active substances, new indicative areas of active substances, new methods of examination and treatment, improvement of quality of life, reduction of the duration of the illness or cost-benefit evaluations.

German institutes, such as the Joint Federal Committee (Gemeinsamer Bundesaussschuss) or the IQWIG, have been given SGB V. The Joint Federal Committee in particular has a decisive influence on the real supply and treatment situation. This can be done through decisions or guidelines. Comments may or may need to be sought.

Did you know that the top organization of medical technology manufacturers in the SGB V also played a role? These are then included when it comes to ensuring the quality of the service or the assessment of new methods of examination and Treatment (look after §§ 92, 135,137c, 137e SGB V).

We are constantly experiencing the fact that international medical technology manufacturers and LifeScience companies are not fully aware of the importance of SGB V for distribution in Germany.

Continue Reading "International manufacturers are hard to reach the German market"

The new European Medical Device Regulation (MDR) and the EU Regulation on In Vitro Diagnostics (IVDR) will replace the existing Medical Device Directives. The timetable for the publication has shifted further. Meanwhile one goes from summer 2017 out. Manufacturers are doing well to deal with the new regulations and to use the time. In particular, non-EU manufacturers with a medical device should address new requirements. Non-EU manufacturers who do not have a branch in the EU must do so by means of a proxy. This…Continue Reading “EU MDR and EU IVDR (In Vitro Diagnostic)”

The intensified market monitoring activities for medical devices across the EU as part of the EU’s PIP Action Plan have resulted in the fact that several conformity assessment bodies in Europe and Switzerland are no longer able to continue their activities in the field of certification of medical devices. This fact has consequences for manufacturers of medical devices.

The 55 Joint Assessments carried out so far (ie, international inspections of the conformity assessment bodies) have led to a reduction in the number of European and Swiss conformity assessment bodies from around 80 to under 60. In addition, the scope of the designations of conformity assessment bodies has also been partially restricted. This means that there are currently about 3,000 EC certificates without monitoring by conformity assessment bodies.

Many manufacturers have to find a new conformity assessment body that will certify their products. This process is not easy and can take up to one year. From a regulatory perspective, the validity of CE certificates in this transitional period has not been conclusively clarified. This raises the question of the further marketing of medical devices with relevant CE certificates for the first time.

A European procedure provides for a period of 12 months for the manufacturers to restore the regulatory requirements. However, prerequisites are that the regulatory requirements are all met, a known or recognized risk is not present, the manufacturer has demonstrably initiated a renewal of the certificate and the manufacturer can prove the status of the product.

This information is not binding.

Continue Reading "Dealing with CE Certificates after tightening"

Clinical utility in the sense of the new medical product regulation describes the positive effects of a product on the health of a person in the sense of meaningful, measurable and patient-relevant clinical results including diagnostic results or a positive effect on patient management or public health. However, within the framework of the conformity procedure, only the intended use of the medical product can be tested under normal intended use, that is to say, The clinical benefit as stated by the manufacturer. It can be…Continue Reading “EU conformity benefit (MDR 2017) versus German reimbursement benefit”