German Government: No system change for medical devices, but conformity assessment requires amendment

 

On 23 June 2014, the Council of Experts for the assessment of developments in the healthcare sector published its report on current developments in the healthcare sector entitled “Appropriate care – the perspective for rural areas and selected healthcare services”. The report dealt with issues such as the current regulation of medical devices and in particular criticised the following:

• the incomplete data regarding the expenditure of state health insurance companies on medical devices and with respect to the clinical performance of the products,
• the restriction of access to national and European medical device information systems (DIMDI and EUDAMED) to regulatory authorities and the lack of information portals for the public,
• the conformity assessment procedure, in which manufacturers of medical devices are free to choose from a pool of specified and certified assessment bodies (since this means a danger of a “customer relationship” between manufacturers and assessment bodies and there is therefore a risk that the assessment is not guided exclusively by safety aspects, but also by economic considerations).

On the basis of this report, the parliamentary group Bündnis 90/Die Grünen submitted a parliamentary question on 15 August 2014 (BT Paper 18/2359), in which it asked how the German government intended to implement the criticism and recommendations of the Council of Experts.

 

Response of the German Government

The German government commented on this it its response of 2 September 2014 (BT Paper 18/2462). It its response it in particular rejected a Europe-wide authorisation of medical devices (analogous to the procedure for the authorisation of drugs) and adhered to the current system of authorisation by the “specified bodies”. The government stated that there was no reliable indication that state bodies could implement the authorisation of devices better than the “specified bodies”. A system change would, according to the government, also mean more bureaucracy and considerable expense, which was not offset by any “increased protection against product deficits or counterfeit products. The German government is therefore taking the same line as the European Commission, the European Council and the European Parliament (which have not to date demanded any system change with respect to the authorisation process).

The German government nevertheless in view of the report sees the need for the following amendments to existing regulations:

• stricter requirements on the specified bodies and their appointment process,
• clear definition of the requirements according to which the specified bodies have to carry out the conformity assessment test,
• increased coordination and quality assurance of market surveillance.

 

Outlook

The Federal Ministry of Health and the Council of Experts are holding a symposium on 30 September 2014 for the presentation of the results of the report and their discussion with specialists from the relevant sectors. Further indications regarding the future organisation of legislation governing medical devices in Germany can at least be expected to come out of this event.