Regulatory affairs for medical devices

Demar­ca­tion and clas­si­fi­ca­tion reports

Medi­cines and medi­c­inal prod­ucts are regu­lated under different Euro­pean frame­works. Direc­tive 2001/83/EC (MPD) provides the regu­la­tory frame­work for medi­c­inal prod­ucts, while Regu­la­tion (EU) 2017/745 (MDR) describes the regu­la­tory basis for medi­c­inal prod­ucts. In the case of so-called border­line prod­ucts, it is not clear from the outset which regu­la­tory frame­work they fall under. In addi­tion, there are combi­na­tion prod­ucts that must fulfil both the require­ments of the MDR and those of the MPD. It is impor­tant to clarify which require­ment is deci­sive for approval or certi­fi­ca­tion and how the corre­sponding product can be qualified.

Benefit from our exten­sive expe­ri­ence in the field of medical devices and medi­c­inal prod­ucts: We support you in the deci­sion-making process in ques­tions of demar­ca­tion for your product and in the prepa­ra­tion of demar­ca­tion reports for submis­sion to author­i­ties or noti­fied bodies.

Tech­nical documentation

According to Annexes II and III of the MDR product dossiers contain all of the tech­nical infor­ma­tion about the medical device and a descrip­tion of its manu­fac­ture and devel­op­ment. All data regarding intended use and infor­ma­tion on product testing (preclin­ical and clin­ical) must be included in the tech­nical docu­men­ta­tion. We can create and update your tech­nical docu­men­ta­tion, conduct gap analyses and help you with our exten­sive expe­ri­ence to meet regu­la­tory requirements.

Biolog­ical safety

The eval­u­a­tion of biolog­ical safety is a main compo­nent of the essen­tial require­ments of medical devices. In addi­tion to biocom­pat­i­bility test results, you can also use and assess data and test results from the liter­a­ture or clin­ical application.

We help you to create biolog­ical eval­u­a­tion plans to find strate­gies, conduct liter­a­ture research, toxi­co­logic calcu­la­tions and eval­uate all rele­vant data on biocom­pat­i­bility in the biolog­ical safety report.

Risk analysis

The risk analysis iden­ti­fies hazards and enables an assess­ment of the risk based on avail­able infor­ma­tion and reason­ably fore­see­able scenarios. Biolog­ical and clin­ical risks are included in the analysis along with the hazards of improper use and tech­nical factors.

For the successful devel­op­ment and certi­fi­ca­tion of your drug product – espe­cially with regard to biosafety and clin­ical safety – we prepare a well-founded risk manage­ment according to EN ISO 14971 to meet the require­ments of the MDR. These go hand in hand with ensuring the safety of patients, users and third parties.

Clin­ical evaluation

can be eval­u­ated using liter­a­ture data or your own clin­ical tests.

We are happy to advise you which route is possible, feasible or neces­sary for your product and coor­di­nate the proce­dure with you. Our experts conduct exten­sive liter­a­ture research and can create both the clin­ical eval­u­a­tion and clin­ical eval­u­a­tion plan for you, as well as study concepts for clin­ical trials. PMCF studies are included.

Post-market clin­ical follow-up (PMCF) plans

One major element in proving the safety and effi­cacy of a medical device lies in the execu­tion of studies, regis­ters or user surveys of already certi­fied medical devices. These proac­tive PMCF measures must be planned in compli­ance with the latest guid­ance docu­ments and regu­la­tory requirements.

We can support you with the prepa­ra­tion of PMCF plans and the corre­sponding study plans.

Support with certification

On request, we can also take over the following activ­i­ties to build a solid base for your project:

• Contact with the noti­fied bodies
• Prepa­ra­tion and imple­men­ta­tion of a scien­tific consultation
• Support with certification
• Reviewing, opti­mising and prepa­ra­tion your documentation
• Devel­op­ment of your product