The actual Medical Device Directive (MDD) 93/42/EEC and the Active Implantable Medical Device Directive (AIMDD) 90/385/ECC are the basic directives for all kinds of medical devices in Europe. These directives are mandatory for all member states and have to be put into national legislation by the national parliaments within a given time limit. It is not allowed to reduce or change the requirements of the directive but the parliaments can implement additional requirements like the German “Medizinprodukteberater” (consultant for medical devices) in §31 of the German medical device law.
In contrast to the Medical Device Directive the Medical Device Regulation (MDR) comes directly from the European Commission in Brussels without any approval by the national parliaments and has to be applied as European, supranational law within a given time limit. Additional national requirements resolved by the national parliaments are possible.
One of the reasons for the new MDR was the PIP-scandal: One manufacturer used the cheaper industrial silicon for breast implants instead of the ultra-pure medical silicon. Once this scandal had been made known publicly the Commission decided to tighten up the directive to prevent this kind of criminal process.