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.

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The self-payout market in the German healthcare sector is booming. Approximately one billion euros are spent by physicians estimated annually with self-pay services (IGEL services). German physicians have the opportunity to offer patients financed by patients free of charge. IGEL services are not included in the statutory health insurance list. Patients were also consulted on IGEL services. Thirty-seven percent consider IGEL services negative and 26 percent negative. Thus the overwhelming part of IGEL sees services as negative. What can be explained? From the rational employment…Continue Reading “Evidence of the benefits of self-pay services”

Method evaluation (according to § 135 and 137c SGB V) and testing of examination and treatment methods (according to § 137e SGB V) The G-BA has the statutory mandate to ensure the adequate, appropriate and economic care of the insured according to scientific criteria through its guidelines. Within the framework of a structured evaluation procedure, G-BA reviews diagnostic and therapeutic methods – Use, – medical necessity and – Economics. For new methods of examination and treatment, the benefits of which are not yet sufficiently documented,…Continue Reading “German Market Access – Method evaluation and testing of examination and treatment methods”

Inpatient treatment – New examination and treatment methods for medical devices in a high risk category with a new method The G-BA to § 137h SGB V the task of evaluating stationary Viable examination and treatment methods, for the first time from a hospital, a request is made on additional charges for the compensation. Lying in a method before all those conditions, evaluated the G-BA, whether the benefits of the method is to be regarded as occupied or whether it has the potential of a…Continue Reading “Inpatient Treatment – high risk categorie”